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| Product Label | Applicant | BLA Number | Proprietary Name | Proper Name | License Type | Strength | Dosage Form | Route of Administration | Product Presentation | Marketing Status | Licensure | Approval Date | Inter. Approval Date | Ref. Product Proper Name | Ref. Product Proprietary Name | Supplement Number | Submission Type | Inter. Supplement Number | License Number | Product Number | Center | Date of First Licensure | Exclusivity Expiration Date | First Inter. Excl. Exp. Date | Ref. Product Excl. Exp. Date | Orphan Exclusivity Expiration Date | Patent List Provided |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Merck Sharp & Dohme LLC | 101062 | N/A | Antivenin (Latrodectus mactans) | 351(a) | NLT6000U | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 13, 1936 | 0 | Original | 0002 | 001 | CBER | ||||||||||
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Merck Sharp & Dohme LLC | 101062 | N/A | Antivenin (Latrodectus mactans) | 351(a) | NLT6000U | For Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | February 13, 1936 | 0 | Original | 0002 | 002 | CBER | ||||||||||
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Wyeth Pharmaceuticals LLC | 101099 | N/A | Antivenin (Micrurus fulvius) | 351(a) | 10ML | For Injection | Intravenous | Vial | Rx | Licensed | August 28, 1967 | 0 | Original | 0003 | 001 | CBER | ||||||||||
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Ferring Pharmaceuticals Inc. | 017055 | A.P.L. | chorionic gonadotropin | 351(a) | 5,000UNITS | For Injection | Intramuscular | Single-Dose Vial | Disc | Licensed | December 13, 1974 | Original | 2112 | 001 | CDER | |||||||||||
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Ferring Pharmaceuticals Inc. | 017055 | A.P.L. | chorionic gonadotropin | 351(a) | 10,000UNITS | For Injection | Intramuscular | Single-Dose Vial | Disc | Licensed | December 13, 1974 | Original | 2112 | 002 | CDER | |||||||||||
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Ferring Pharmaceuticals Inc. | 017055 | A.P.L. | chorionic gonadotropin | 351(a) | 20,000UNITS | For Injection | Intramuscular | Single-Dose Vial | Disc | Licensed | December 13, 1974 | Original | 2112 | 003 | CDER | |||||||||||
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Celgene Corporation, a Bristol-Myers Squibb Company | 125736 | Abecma | idecabtagene vicleucel | 351(a) | 300 to 460 X 10^6 CHIMERIC ANTIGEN RECEPTOR (CAR)-POSITIVE T CELLS | Suspension | Intravenous | Bag | Rx | Licensed | March 3, 2021 | 0 | Original | 2252 | 001 | CBER | April 4, 2031 | |||||||||
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Celgene Corporation, a Bristol-Myers Squibb Company | 125736 | Abecma | idecabtagene vicleucel | 351(a) | 300 to 510 X 10^6 CHIMERIC ANTIGEN RECEPTOR (CAR)-POSITIVE T CELLS | Suspension | Intravenous | Bag | Rx | Licensed | April 4, 2024 | 218 | Supplement | 2252 | 002 | CBER | April 4, 2031 | |||||||||
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Pfizer Inc. | 761118 | Abrilada | adalimumab-afzb | 351(k) Interchangeable | 40MG/0.8ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | November 15, 2019 | October 4, 2023 | adalimumab | Humira | Original | 7 | 2001 | 001 | CDER | |||||||
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Pfizer Inc. | 761118 | Abrilada | adalimumab-afzb | 351(k) Interchangeable | 40MG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | November 15, 2019 | October 4, 2023 | adalimumab | Humira | Original | 7 | 2001 | 002 | CDER | |||||||
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Pfizer Inc. | 761118 | Abrilada | adalimumab-afzb | 351(k) Interchangeable | 20MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | November 15, 2019 | October 4, 2023 | adalimumab | Humira | Original | 7 | 2001 | 003 | CDER | |||||||
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Pfizer Inc. | 761118 | Abrilada | adalimumab-afzb | 351(k) Interchangeable | 10MG/0.2ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | November 15, 2019 | October 4, 2023 | adalimumab | Humira | Original | 7 | 2001 | 004 | CDER | |||||||
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Pfizer Inc. | 761118 | Abrilada | adalimumab-afzb | 351(k) Interchangeable | 40MG/0.8ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | November 15, 2019 | October 4, 2023 | adalimumab | Humira | Original | 7 | 2001 | 005 | CDER | |||||||
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Pfizer Inc. | 125769 | Abrysvo | Respiratory Syncytial Virus Vaccine | 351(a) | 120UG | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | May 31, 2023 | 0 | Original | 2001 | 001 | CBER | ||||||||||
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Emergent Product Development Gaithersburg, Inc. | 125158 | Acam2000 | Smallpox (Vaccinia) Vaccine, Live | 351(a) | 1.0- 5.0 X 10^8 PFU/ML | Suspension | Percutaneous | Multi-Dose Vial | Rx | Licensed | August 31, 2007 | 0 | Original | 2089 | 001 | CBER | ||||||||||
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Emergent Biosolutions Canada Inc. | 021538 | Accretropin | somatropin | 351(a) | 5MG/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | January 23, 2008 | Original | 2084 | 001 | CDER | |||||||||||
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Genentech, Inc. | 125276 | Actemra | tocilizumab | 351(a) | 80MG/4ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | January 8, 2010 | Original | 1048 | 001 | CDER | February 28, 2025 | Yes | |||||||||
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Genentech, Inc. | 125276 | Actemra | tocilizumab | 351(a) | 200MG/10ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | January 8, 2010 | Original | 1048 | 002 | CDER | February 28, 2025 | Yes | |||||||||
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Genentech, Inc. | 125276 | Actemra | tocilizumab | 351(a) | 400MG/20ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | January 8, 2010 | Original | 1048 | 003 | CDER | February 28, 2025 | Yes | |||||||||
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Genentech, Inc. | 125472 | Actemra | tocilizumab | 351(a) | 162MG/0.9ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | October 21, 2013 | Original | 1048 | 001 | CDER | September 4, 2028 | ||||||||||
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Genentech, Inc. | 125472 | Actemra | tocilizumab | 351(a) | 162MG/0.9ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | November 19, 2018 | 29 | Supplement | 1048 | 002 | CDER | September 4, 2028 | |||||||||
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Sanofi Winthrop Industrie | 103935 | Acthib,Omnihib | Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) | 351(a) | 24UG | For Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | February 4, 2000 | 0 | Original | 1724 | 001 | CBER | ||||||||||
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Ferring Pharmaceuticals Inc. | 020162 | Acthrel | corticorelin ovine triflutate | 351(a) | 100MCG | For Injection | Intravenous | Single-Dose Vial | Disc | Licensed | May 23, 1996 | Original | 2112 | 001 | CDER | May 23, 2003 | ||||||||||
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Horizon Therapeutics Ireland DAC | 103836 | Actimmune | interferon gamma-1b | 351(a) | 100MCG(2MILLION INTERNATIONAL UNITS)/0.5ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | February 25, 1999 | Original | 2022 | 001 | CDER | February 10, 2007 | ||||||||||
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Genentech, Inc. | 103172 | Activase | alteplase | 351(a) | 50MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 13, 1987 | Original | 1048 | 001 | CDER | |||||||||||
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Genentech, Inc. | 103172 | Activase | alteplase | 351(a) | 100MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 13, 1987 | Original | 1048 | 002 | CDER | |||||||||||
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Sanofi Pasteur Limited | 125111 | Adacel | Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed | 351(a) | 0.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | June 10, 2005 | 0 | Original | 1726 | 001 | CBER | ||||||||||
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Leadiant Biosciences, Inc | 019818 | Adagen | pegademase bovine | 351(a) | 375UNITS/1.5ML (250UNITS/ML) | Injection | Intramuscular | Single-Dose Vial | Disc | Licensed | March 21, 1990 | Original | 2073 | 001 | CDER | March 21, 1997 | ||||||||||
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Novartis Pharmaceuticals Corporation | 761128 | Adakveo | crizanlizumab-tmca | 351(a) | 100MG/10ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 15, 2019 | Original | 1244 | 001 | CDER | November 15, 2026 | ||||||||||
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LEO Pharma A/S | 761180 | Adbry | tralokinumab-ldrm | 351(a) | 150MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | December 27, 2021 | Original | 2169 | 001 | CDER | |||||||||||
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LEO Pharma A/S | 761180 | Adbry | tralokinumab-ldrm | 351(a) | 300MG/2ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | June 12, 2024 | 5 | Supplement | 2169 | 002 | CDER | ||||||||||
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Seagen Inc. | 125388 | Adcetris | brentuximab vedotin | 351(a) | 50MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 19, 2011 | Original | 2257 | 001 | CDER | November 10, 2029 | ||||||||||
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Sanofi-Aventis U.S. LLC | 208471 | Adlyxin | lixisenatide | 351(a) | 150MCG/3ML (50MCG/ML) | Injection | Subcutaneous | Autoinjector | Disc | Licensed | July 27, 2016 | Original | 1752 | 001 | CDER | |||||||||||
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Sanofi-Aventis U.S. LLC | 208471 | Adlyxin | lixisenatide | 351(a) | 300MCG/3ML (100MCG/ML) | Injection | Subcutaneous | Autoinjector | Disc | Licensed | July 27, 2016 | Original | 1752 | 002 | CDER | |||||||||||
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Sanofi-Aventis U.S. LLC | 209196 | Admelog | insulin lispro | 351(a) | 1,000UNITS/10ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Multi-Dose Vial | Rx | Licensed | December 11, 2017 | Original | 1752 | 001 | CDER | |||||||||||
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Sanofi-Aventis U.S. LLC | 209196 | Admelog | insulin lispro | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | December 11, 2017 | Original | 1752 | 002 | CDER | |||||||||||
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Sanofi-Aventis U.S. LLC | 209196 | Admelog | insulin lispro | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Multi-Dose Vial | Rx | Licensed | October 19, 2018 | 1 | Supplement | 1752 | 003 | CDER | ||||||||||
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Ferring Pharmaceuticals A/S | 125700 | Adstiladrin | nadofaragene firadenovec-vncg | 351(a) | 3x10^11 viral particles (vp)/mL | For Suspension | Intravesical | Single-Dose Vial | Rx | Licensed | December 16, 2022 | 0 | Original | 2222 | 001 | CBER | December 16, 2022 | December 16, 2034 | ||||||||
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Biogen Inc. | 761178 | Aduhelm | aducanumab-avwa | 351(a) | 170MG/1.7ML (100MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 7, 2021 | Original | 1697 | 001 | CDER | |||||||||||
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Biogen Inc. | 761178 | Aduhelm | aducanumab-avwa | 351(a) | 300MG/3ML (100MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 7, 2021 | Original | 1697 | 002 | CDER | |||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 125063 | Advate | Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method | 351(a) | 1500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 25, 2003 | 0 | Original | 1898 | 001 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 125063 | Advate | Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 25, 2003 | 0 | Original | 1898 | 002 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 125063 | Advate | Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method | 351(a) | 250IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 25, 2003 | 0 | Original | 1898 | 003 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 125063 | Advate | Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 25, 2003 | 0 | Original | 1898 | 004 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 125063 | Advate | Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method | 351(a) | 2000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 12, 2006 | 135 | Supplement | 1898 | 005 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 125063 | Advate | Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method | 351(a) | 3000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 3, 2007 | 279 | Supplement | 1898 | 006 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 125063 | Advate | Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method | 351(a) | 4,000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 12, 2012 | 948 | Supplement | 1898 | 007 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 125566 | Adynovate | Antihemophilic Factor (Recombinant), PEGylated | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 13, 2015 | 0 | Original | 1898 | 001 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 125566 | Adynovate | Antihemophilic Factor (Recombinant), PEGylated | 351(a) | 2000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 13, 2015 | 0 | Original | 1898 | 002 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 125566 | Adynovate | Antihemophilic Factor (Recombinant), PEGylated | 351(a) | 250IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 13, 2015 | 0 | Original | 1898 | 003 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 125566 | Adynovate | Antihemophilic Factor (Recombinant), PEGylated | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 13, 2015 | 0 | Original | 1898 | 004 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 125566 | Adynovate | Antihemophilic Factor (Recombinant), PEGylated | 351(a) | 1500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 25, 2016 | 104 | Supplement | 1898 | 005 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 125566 | Adynovate | Antihemophilic Factor (Recombinant), PEGylated | 351(a) | 750IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 25, 2016 | 104 | Supplement | 1898 | 006 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 125566 | Adynovate | Antihemophilic Factor (Recombinant), PEGylated | 351(a) | 3000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 13, 2017 | 152 | Supplement | 1898 | 007 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 125795 | ADZYNMA | ADAMTS13, recombinant-krhn | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 9, 2023 | 0 | Original | 1898 | 001 | CBER | November 9, 2030 | |||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 125795 | ADZYNMA | ADAMTS13, recombinant-krhn | 351(a) | 1500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 9, 2023 | 0 | Original | 1898 | 002 | CBER | November 9, 2030 | |||||||||
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Seqirus Pty Ltd. | 125254 | Afluria, Afluria Quadrivalent | Influenza Vaccine | 351(a) | 225UG | Injection | Intramuscular | Multi-Dose Vial | Rx | Licensed | September 28, 2007 | 0 | Original | 2044 | 001 | CBER | ||||||||||
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Seqirus Pty Ltd. | 125254 | Afluria, Afluria Quadrivalent | Influenza Vaccine | 351(a) | 45UG/.5ML | Injection | Intramuscular | Syringe | Rx | Licensed | September 28, 2007 | 0 | Original | 2044 | 002 | CBER | ||||||||||
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Seqirus Pty Ltd. | 125254 | Afluria, Afluria Quadrivalent | Influenza Vaccine | 351(a) | 60UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Disc | Licensed | August 26, 2016 | 565 | Supplement | 2044 | 003 | CBER | ||||||||||
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Seqirus Pty Ltd. | 125254 | Afluria, Afluria Quadrivalent | Influenza Vaccine | 351(a) | 60UG/.5ML | Injection | Intramuscular | Multi-Dose Vial | Disc | Licensed | August 26, 2016 | 565 | Supplement | 2044 | 004 | CBER | ||||||||||
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Seqirus Pty Ltd. | 125254 | Afluria, Afluria Quadrivalent | Influenza Vaccine | 351(a) | 30UG/.25ML | Injection | Intramuscular | Pre-Filled Syringe | Disc | Licensed | October 4, 2018 | 692 | Supplement | 2044 | 005 | CBER | ||||||||||
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Mannkind Corporation | 022472 | Afrezza | insulin human | 351(a) | 4UNITS/INH | Powder | Inhalation | Single-Dose Cartridge | Rx | Licensed | June 27, 2014 | Original | 2190 | 001 | CDER | |||||||||||
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Mannkind Corporation | 022472 | Afrezza | insulin human | 351(a) | 8UNITS/INH | Powder | Inhalation | Single-Dose Cartridge | Rx | Licensed | June 27, 2014 | Original | 2190 | 002 | CDER | |||||||||||
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Mannkind Corporation | 022472 | Afrezza | insulin human | 351(a) | 12UNITS/INH | Powder | Inhalation | Single-Dose Cartridge | Rx | Licensed | April 17, 2015 | 3 | Supplement | 2190 | 003 | CDER | ||||||||||
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CSL Behring Lengnau AG | 125591 | Afstyla | Antihemophilic Factor (Recombinant), Single Chain | 351(a) | 3000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 25, 2016 | 0 | Original | 2009 | 001 | CBER | ||||||||||
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CSL Behring Lengnau AG | 125591 | Afstyla | Antihemophilic Factor (Recombinant), Single Chain | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 25, 2016 | 0 | Original | 2009 | 002 | CBER | ||||||||||
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CSL Behring Lengnau AG | 125591 | Afstyla | Antihemophilic Factor (Recombinant), Single Chain | 351(a) | 250IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 25, 2016 | 0 | Original | 2009 | 003 | CBER | ||||||||||
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CSL Behring Lengnau AG | 125591 | Afstyla | Antihemophilic Factor (Recombinant), Single Chain | 351(a) | 2000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 25, 2016 | 0 | Original | 2009 | 004 | CBER | ||||||||||
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CSL Behring Lengnau AG | 125591 | Afstyla | Antihemophilic Factor (Recombinant), Single Chain | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 25, 2016 | 0 | Original | 2009 | 005 | CBER | ||||||||||
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CSL Behring Lengnau AG | 125591 | Afstyla | Antihemophilic Factor (Recombinant), Single Chain | 351(a) | 2500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 31, 2017 | 47 | Supplement | 2009 | 006 | CBER | ||||||||||
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CSL Behring Lengnau AG | 125591 | Afstyla | Antihemophilic Factor (Recombinant), Single Chain | 351(a) | 1500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 31, 2017 | 47 | Supplement | 2009 | 007 | CBER | ||||||||||
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Seqirus Inc. | 125297 | Agriflu | Influenza Virus Vaccine | 351(a) | .05ML | Injection | Intramuscular | Syringe | Disc | Licensed | November 27, 2009 | 0 | Original | 2049 | 001 | CBER | ||||||||||
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Formycon AG | 761378 | Ahzantive | aflibercept-mrbb | 351(k) Biosimilar | 2MG/0.05ML | Injection | Intravitreal | Single-Dose Vial | Rx | Licensed | June 28, 2024 | aflibercept | Eylea | Original | 2322 | 001 | CDER | |||||||||
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Formycon AG | 761378 | Ahzantive | aflibercept-mrbb | 351(k) Biosimilar | 2MG/0.05ML | Injection | Intravitreal | Pre-Filled Syringe | Rx | Licensed | April 17, 2025 | aflibercept | Eylea | 1 | Supplement | 2322 | 002 | CDER | ||||||||
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Amgen Inc. | 761077 | Aimovig | erenumab-aooe | 351(a) | 70MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | May 17, 2018 | Original | 1080 | 001 | CDER | |||||||||||
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Amgen Inc. | 761077 | Aimovig | erenumab-aooe | 351(a) | 70MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | May 17, 2018 | Original | 1080 | 002 | CDER | |||||||||||
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Amgen Inc. | 761077 | Aimovig | erenumab-aooe | 351(a) | 140MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | March 11, 2019 | 1 | Supplement | 1080 | 003 | CDER | ||||||||||
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Amgen Inc. | 761077 | Aimovig | erenumab-aooe | 351(a) | 140MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | March 11, 2019 | 1 | Supplement | 1080 | 004 | CDER | ||||||||||
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Teva Branded Pharmaceutical Products R&D, Inc. | 761089 | Ajovy | fremanezumab-vfrm | 351(a) | 225MG/1.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | September 14, 2018 | Original | 2016 | 001 | CDER | |||||||||||
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Teva Branded Pharmaceutical Products R&D, Inc. | 761089 | Ajovy | fremanezumab-vfrm | 351(a) | 225MG/1.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | January 27, 2020 | 2 | Supplement | 2016 | 002 | CDER | ||||||||||
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Grifols Therapeutics LLC | 101138 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | Albumin (Human) | 351(a) | 2.5G/50ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 21, 1942 | 0 | Original | 1871 | 001 | CBER | ||||||||||
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Grifols Therapeutics LLC | 101138 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | Albumin (Human) | 351(a) | 25G/100ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 21, 1942 | 0 | Original | 1871 | 002 | CBER | ||||||||||
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Grifols Therapeutics LLC | 101138 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | Albumin (Human) | 351(a) | 20G/100ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 21, 1942 | 0 | Original | 1871 | 003 | CBER | ||||||||||
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Grifols Therapeutics LLC | 101138 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | Albumin (Human) | 351(a) | 10G/50ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 21, 1942 | 0 | Original | 1871 | 004 | CBER | ||||||||||
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Grifols Therapeutics LLC | 101138 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | Albumin (Human) | 351(a) | 12.5G/50ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 21, 1942 | 0 | Original | 1871 | 005 | CBER | ||||||||||
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Grifols Therapeutics LLC | 101138 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | Albumin (Human) | 351(a) | 5G/20ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 21, 1942 | 0 | Original | 1871 | 006 | CBER | ||||||||||
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Grifols Therapeutics LLC | 101138 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | Albumin (Human) | 351(a) | 25G/500ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 21, 1942 | 0 | Original | 1871 | 007 | CBER | ||||||||||
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Grifols Therapeutics LLC | 101138 | Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 | Albumin (Human) | 351(a) | 12.5G/250ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 21, 1942 | 0 | Original | 1871 | 008 | CBER | ||||||||||
|
|
CSL Behring LLC | 103955 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | Albumin (Human) | 351(a) | 10G/50ML | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | March 17, 2000 | 0 | Original | 1767 | 001 | CBER | ||||||||||
|
|
CSL Behring LLC | 103955 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | Albumin (Human) | 351(a) | 20G/100ML | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | March 17, 2000 | 0 | Original | 1767 | 002 | CBER | ||||||||||
|
|
CSL Behring LLC | 103955 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | Albumin (Human) | 351(a) | 25G/100ML | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | July 17, 2000 | 0 | Original | 1767 | 003 | CBER | ||||||||||
|
|
CSL Behring LLC | 103955 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | Albumin (Human) | 351(a) | 5G/20ML | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | March 17, 2000 | 0 | Original | 1767 | 004 | CBER | ||||||||||
|
|
CSL Behring LLC | 103955 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | Albumin (Human) | 351(a) | 2.5G/50ML | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | March 17, 2000 | 0 | Original | 1767 | 005 | CBER | ||||||||||
|
|
CSL Behring LLC | 103955 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | Albumin (Human) | 351(a) | 12.5G/50ML | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | July 17, 2000 | 0 | Original | 1767 | 006 | CBER | ||||||||||
|
|
CSL Behring LLC | 103955 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | Albumin (Human) | 351(a) | 12.5G/250ML | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | July 17, 2000 | 0 | Original | 1767 | 007 | CBER | ||||||||||
|
|
CSL Behring LLC | 103955 | Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 | Albumin (Human) | 351(a) | 25G/500ML | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | July 17, 2000 | 0 | Original | 1767 | 008 | CBER | ||||||||||
|
|
Bio Products Laboratory Limited | 125644 | Albuminex | Albumin (Human)-kjda | 351(a) | 12.5G/50ML | Solution | Intravenous | Single-Dose Vial | Rx | Licensed | June 19, 2018 | 0 | Original | 1811 | 001 | CBER | ||||||||||
|
|
Bio Products Laboratory Limited | 125644 | Albuminex | Albumin (Human)-kjda | 351(a) | 25G/100ML | Solution | Intravenous | Single-Dose Vial | Rx | Licensed | June 19, 2018 | 0 | Original | 1811 | 002 | CBER | ||||||||||
|
|
Bio Products Laboratory Limited | 125644 | Albuminex | Albumin (Human)-kjda | 351(a) | 12.5G/250ML | Solution | Intravenous | Single-Dose Vial | Rx | Licensed | June 19, 2018 | 0 | Original | 1811 | 003 | CBER | ||||||||||
|
|
Bio Products Laboratory Limited | 125644 | Albuminex | Albumin (Human)-kjda | 351(a) | 25G/500ML | Solution | Intravenous | Single-Dose Vial | Rx | Licensed | June 19, 2018 | 0 | Original | 1811 | 004 | CBER | ||||||||||
|
|
CSL Behring AG | 102366 | Alburx | Albumin (Human) | 351(a) | 25G/100mL | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 23, 1976 | 0 | Original | 1766 | 001 | CBER | ||||||||||
|
|
CSL Behring AG | 102366 | Alburx | Albumin (Human) | 351(a) | 25G/500ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 23, 1976 | 0 | Original | 1766 | 002 | CBER | ||||||||||
|
|
CSL Behring AG | 102366 | Alburx | Albumin (Human) | 351(a) | 12.5G/50ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 23, 1976 | 0 | Original | 1766 | 003 | CBER | ||||||||||
|
|
CSL Behring AG | 102366 | Alburx | Albumin (Human) | 351(a) | 12.5G/250ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 23, 1976 | 0 | Original | 1766 | 004 | CBER | ||||||||||
|
|
Grifols Biologicals LLC | 102478 | Albutein | Albumin (Human) | 351(a) | 10G/50ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 15, 1978 | 0 | Original | 1694 | 001 | CBER | ||||||||||
|
|
Grifols Biologicals LLC | 102478 | Albutein | Albumin (Human) | 351(a) | 20G/100ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 15, 1978 | 0 | Original | 1694 | 002 | CBER | ||||||||||
|
|
Grifols Biologicals LLC | 102478 | Albutein | Albumin (Human) | 351(a) | 25G/100ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 15, 1978 | 0 | Original | 1694 | 003 | CBER | ||||||||||
|
|
Grifols Biologicals LLC | 102478 | Albutein | Albumin (Human) | 351(a) | 2.5G/50ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 15, 1978 | 0 | Original | 1694 | 004 | CBER | ||||||||||
|
|
Grifols Biologicals LLC | 102478 | Albutein | Albumin (Human) | 351(a) | 12.5G/50ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 15, 1978 | 0 | Original | 1694 | 005 | CBER | ||||||||||
|
|
Grifols Biologicals LLC | 102478 | Albutein | Albumin (Human) | 351(a) | 5G/20ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 15, 1978 | 0 | Original | 1694 | 006 | CBER | ||||||||||
|
|
Grifols Biologicals LLC | 102478 | Albutein | Albumin (Human) | 351(a) | 12.5ML/250ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 15, 1978 | 0 | Original | 1694 | 007 | CBER | ||||||||||
|
|
Grifols Biologicals LLC | 102478 | Albutein | Albumin (Human) | 351(a) | 25G/500ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 15, 1978 | 0 | Original | 1694 | 008 | CBER | ||||||||||
|
|
Grifols Biologicals LLC | 102478 | Albutein | Albumin (Human) | 351(a) | 5G/100ML | Injection | Intravenous | Bag | Disc | Licensed | November 29, 2022 | 5570 | Supplement | 1694 | 009 | CBER | ||||||||||
|
|
BioMarin Pharmaceutical Inc. | 125058 | Aldurazyme | laronidase | 351(a) | 2.9MG/5ML (0.58MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 30, 2003 | Original | 1649 | 001 | CDER | April 30, 2010 | ||||||||||
|
|
AIM ImmunoTech Inc. | 103158 | Alferon N Injection | interferon alfa-n3 (human leukocyte derived) | 351(a) | 5MILLION IU/1ML | Injection | Intravenous | Vial | Disc | Licensed | October 10, 1989 | Original | 1703 | 001 | CDER | |||||||||||
|
|
Novo Nordisk Inc. | 761315 | Alhemo | concizumab-mtci | 351(a) | 60MG/1.5ML (40MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | December 20, 2024 | Original | 1261 | 001 | CDER | |||||||||||
|
|
Novo Nordisk Inc. | 761315 | Alhemo | concizumab-mtci | 351(a) | 150MG/1.5ML (100MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | December 20, 2024 | Original | 1261 | 002 | CDER | |||||||||||
|
|
Novo Nordisk Inc. | 761315 | Alhemo | concizumab-mtci | 351(a) | 300MG/3ML (100MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | December 20, 2024 | Original | 1261 | 003 | CDER | |||||||||||
|
|
SSM Cardinal Glennon Children's Medical Center | 125413 | Allocord | HPC, Cord Blood | 351(a) | TOTAL NUCLEATED CELLS CELL/ML | Injection | Intravenous | Bag | Rx | Licensed | May 30, 2013 | 0 | Original | 1873 | 001 | CBER | ||||||||||
|
|
Grifols Biologicals LLC | 102475 | Alphanate | Antihemophilic Factor/von Willebrand Factor Complex (Human) | 351(a) | 250IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 15, 1978 | 0 | Original | 1694 | 001 | CBER | January 31, 2014 | |||||||||
|
|
Grifols Biologicals LLC | 102475 | Alphanate | Antihemophilic Factor/von Willebrand Factor Complex (Human) | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 15, 1978 | 0 | Original | 1694 | 002 | CBER | January 31, 2014 | |||||||||
|
|
Grifols Biologicals LLC | 102475 | Alphanate | Antihemophilic Factor/von Willebrand Factor Complex (Human) | 351(a) | 1500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 15, 1978 | 0 | Original | 1694 | 003 | CBER | January 31, 2014 | |||||||||
|
|
Grifols Biologicals LLC | 102475 | Alphanate | Antihemophilic Factor/von Willebrand Factor Complex (Human) | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 15, 1978 | 0 | Original | 1694 | 004 | CBER | January 31, 2014 | |||||||||
|
|
Grifols Biologicals LLC | 102475 | Alphanate | Antihemophilic Factor/von Willebrand Factor Complex (Human) | 351(a) | 2000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 26, 2014 | 5400 | Supplement | 1694 | 005 | CBER | January 31, 2014 | |||||||||
|
|
Grifols Biologicals LLC | 103249 | Alphanine, Alphanine Hp, Alphanine Sd | Coagulation Factor IX (Human) | 351(a) | 500IU | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 31, 1990 | 0 | Original | 1694 | 001 | CBER | December 31, 1997 | |||||||||
|
|
Grifols Biologicals LLC | 103249 | Alphanine, Alphanine Hp, Alphanine Sd | Coagulation Factor IX (Human) | 351(a) | 1000IU | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 31, 1990 | 0 | Original | 1694 | 002 | CBER | December 31, 1997 | |||||||||
|
|
Grifols Biologicals LLC | 103249 | Alphanine, Alphanine Hp, Alphanine Sd | Coagulation Factor IX (Human) | 351(a) | 250IU | Injection | Intravenous | Single-Dose Vial | Disc | Licensed | December 31, 1990 | 0 | Original | 1694 | 003 | CBER | December 31, 1997 | |||||||||
|
|
Grifols Biologicals LLC | 103249 | Alphanine, Alphanine Hp, Alphanine Sd | Coagulation Factor IX (Human) | 351(a) | 1500IU | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 31, 1990 | 0 | Original | 1694 | 004 | CBER | December 31, 1997 | |||||||||
|
|
Bioverativ Therapeutics, Inc. | 125444 | Alprolix | Coagulation Factor IX (Recombinant), Fc Fusion Protein | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 28, 2014 | 0 | Original | 2078 | 001 | CBER | March 28, 2021 | |||||||||
|
|
Bioverativ Therapeutics, Inc. | 125444 | Alprolix | Coagulation Factor IX (Recombinant), Fc Fusion Protein | 351(a) | 2000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 28, 2014 | 0 | Original | 2078 | 002 | CBER | March 28, 2021 | |||||||||
|
|
Bioverativ Therapeutics, Inc. | 125444 | Alprolix | Coagulation Factor IX (Recombinant), Fc Fusion Protein | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 28, 2014 | 0 | Original | 2078 | 003 | CBER | March 28, 2021 | |||||||||
|
|
Bioverativ Therapeutics, Inc. | 125444 | Alprolix | Coagulation Factor IX (Recombinant), Fc Fusion Protein | 351(a) | 3000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 28, 2014 | 0 | Original | 2078 | 004 | CBER | March 28, 2021 | |||||||||
|
|
Bioverativ Therapeutics, Inc. | 125444 | Alprolix | Coagulation Factor IX (Recombinant), Fc Fusion Protein | 351(a) | 250IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 18, 2016 | 175 | Supplement | 2078 | 005 | CBER | March 28, 2021 | |||||||||
|
|
Bioverativ Therapeutics, Inc. | 125444 | Alprolix | Coagulation Factor IX (Recombinant), Fc Fusion Protein | 351(a) | 4000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 14, 2016 | 286 | Supplement | 2078 | 006 | CBER | March 28, 2021 | |||||||||
|
|
Bioverativ Therapeutics, Inc. | 125771 | ALTUVIIIO | antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl | 351(a) | 250IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 22, 2023 | 0 | Original | 2078 | 001 | CBER | February 22, 2030 | |||||||||
|
|
Bioverativ Therapeutics, Inc. | 125771 | ALTUVIIIO | antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 22, 2023 | 0 | Original | 2078 | 002 | CBER | February 22, 2030 | |||||||||
|
|
Bioverativ Therapeutics, Inc. | 125771 | ALTUVIIIO | antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl | 351(a) | 750IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 22, 2023 | 0 | Original | 2078 | 003 | CBER | February 22, 2030 | |||||||||
|
|
Bioverativ Therapeutics, Inc. | 125771 | ALTUVIIIO | antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 22, 2023 | 0 | Original | 2078 | 004 | CBER | February 22, 2030 | |||||||||
|
|
Bioverativ Therapeutics, Inc. | 125771 | ALTUVIIIO | antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl | 351(a) | 2000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 22, 2023 | 0 | Original | 2078 | 005 | CBER | February 22, 2030 | |||||||||
|
|
Bioverativ Therapeutics, Inc. | 125771 | ALTUVIIIO | antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl | 351(a) | 3000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 22, 2023 | 0 | Original | 2078 | 006 | CBER | February 22, 2030 | |||||||||
|
|
Bioverativ Therapeutics, Inc. | 125771 | ALTUVIIIO | antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl | 351(a) | 4000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 22, 2023 | 0 | Original | 2078 | 007 | CBER | February 22, 2030 | |||||||||
|
|
GC Biopharma Corp. | 125743 | Alyglo | immune globulin intravenous, human-stwk | 351(a) | 10% 100MG/ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 15, 2023 | 0 | Original | 2033 | 001 | CBER | ||||||||||
|
|
Amneal Pharmaceuticals LLC | 761231 | Alymsys | bevacizumab-maly | 351(k) Biosimilar | 100MG/4ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 13, 2022 | bevacizumab | Avastin | Original | 2241 | 001 | CDER | |||||||||
|
|
Amneal Pharmaceuticals LLC | 761231 | Alymsys | bevacizumab-maly | 351(k) Biosimilar | 400MG/16ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 13, 2022 | bevacizumab | Avastin | Original | 2241 | 002 | CDER | |||||||||
|
|
Astellas Pharma US, Inc. | 125036 | Amevive | alefacept | 351(a) | 7.5MG | For Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | January 30, 2003 | Original | 1748 | 001 | CDER | |||||||||||
|
|
Astellas Pharma US, Inc. | 125036 | Amevive | alefacept | 351(a) | 15MG | For Injection | Intramuscular | Single-Dose Vial | Disc | Voluntarily Revoked | January 30, 2003 | Original | 1748 | 002 | CDER | |||||||||||
|
|
Amgen Inc. | 761024 | Amjevita | adalimumab-atto | 351(k) Interchangeable | 20MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | September 23, 2016 | August 20, 2024 | adalimumab | Humira | Original | 19 | 1080 | 001 | CDER | |||||||
|
|
Amgen Inc. | 761024 | Amjevita | adalimumab-atto | 351(k) Interchangeable | 40MG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | September 23, 2016 | August 20, 2024 | adalimumab | Humira | Original | 19 | 1080 | 002 | CDER | |||||||
|
|
Amgen Inc. | 761024 | Amjevita | adalimumab-atto | 351(k) Interchangeable | 40MG/0.8ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | September 23, 2016 | August 20, 2024 | adalimumab | Humira | Original | 19 | 1080 | 003 | CDER | |||||||
|
|
Amgen Inc. | 761024 | Amjevita | adalimumab-atto | 351(k) Interchangeable | 10MG/0.2ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | April 6, 2023 | August 20, 2024 | adalimumab | Humira | 11 | Supplement | 19 | 1080 | 004 | CDER | ||||||
|
|
Amgen Inc. | 761024 | Amjevita | adalimumab-atto | 351(k) Interchangeable | 20MG/0.2ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | August 14, 2023 | April 7, 2025 | adalimumab | Humira | 15 | Supplement | 23 | 1080 | 005 | CDER | ||||||
|
|
Amgen Inc. | 761024 | Amjevita | adalimumab-atto | 351(k) Interchangeable | 40MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | August 14, 2023 | May 20, 2025 | adalimumab | Humira | 15 | Supplement | 21 | 1080 | 006 | CDER | ||||||
|
|
Amgen Inc. | 761024 | Amjevita | adalimumab-atto | 351(k) Interchangeable | 80MG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | August 14, 2023 | April 7, 2025 | adalimumab | Humira | 15 | Supplement | 23 | 1080 | 007 | CDER | ||||||
|
|
Amgen Inc. | 761024 | Amjevita | adalimumab-atto | 351(k) Interchangeable | 40MG/0.4ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | August 14, 2023 | May 20, 2025 | adalimumab | Humira | 15 | Supplement | 21 | 1080 | 008 | CDER | ||||||
|
|
Amgen Inc. | 761024 | Amjevita | adalimumab-atto | 351(k) Interchangeable | 80MG/0.8ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | August 14, 2023 | April 7, 2025 | adalimumab | Humira | 15 | Supplement | 23 | 1080 | 009 | CDER | ||||||
|
|
Amphastar Pharmaceuticals, Inc. | 021665 | Amphadase | hyaluronidase | 351(a) | 150UNITS/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | October 26, 2004 | Original | 2179 | 001 | CDER | |||||||||||
|
|
Iovance Biotherapeutics, Inc. | 125773 | AMTAGVI | Lifileucel | 351(a) | 7.5x10^9 to 72x10^9Cells | Suspension | Intravenous | Bag | Rx | Licensed | February 16, 2024 | 0 | Original | 2298 | 001 | CBER | February 16, 2024 | February 16, 2036 | February 16, 2031 | |||||||
|
|
Rare Disease Therapeutics, Inc. (RDT) | 125335 | Anascorp | Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection | 351(a) | >/=150 LD50 NEUTRALIZING UNITS | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 3, 2011 | 0 | Original | 1860 | 001 | CBER | August 4, 2018 | |||||||||
|
|
Rare Disease Therapeutics, Inc. (RDT) | 125488 | Anavip | Crotalidae Immune F(ab')2 (Equine) | 351(a) | MINIMUM 780 BOTHROPS ASPER, 790 C.SIMUS, 244 C.ADAMANTEUS, 147 C.ATROX, 185 C.SCUTULATUS, 28 AGKISTRODON CONTORTRIX, 61 A.PISCIVORUS LD50 NEUTRALIZING UNITS/VIAL | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 6, 2015 | 0 | Original | 1860 | 001 | CBER | May 6, 2022 | |||||||||
|
|
CSL Behring LLC | 761367 | Andembry | garadacimab-gxii | 351(a) | 200MG/1.2ML (167MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | June 16, 2025 | Original | 1767 | 001 | CDER | |||||||||||
|
|
CSL Behring LLC | 761367 | Andembry | garadacimab-gxii | 351(a) | 200MG/1.2ML (167MG/ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | June 16, 2025 | Original | 1767 | 002 | CDER | |||||||||||
|
|
AstraZeneca AB | 125586 | Andexxa | Coagulation Factor Xa (Recombinant), Inactivated-zhzo | 351(a) | 100MG | Injection | Intravenous | Single-Dose Vial | Disc | Revoked | May 3, 2018 | 0 | Original | 2059 | 001 | CBER | May 3, 2025 | |||||||||
|
|
AstraZeneca AB | 125586 | Andexxa | Coagulation Factor Xa (Recombinant), Inactivated-zhzo | 351(a) | 200MG | Injection | Intravenous | Single-Dose Vial | Disc | Revoked | December 31, 2018 | 27 | Supplement | 2059 | 002 | CBER | May 3, 2025 | |||||||||
|
|
Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc. | 761336 | Anktiva | nogapendekin alfa inbakicept-pmln | 351(a) | 400MCG/0.4ML | Solution | Intravesical | Single-Dose Vial | Rx | Licensed | April 22, 2024 | Original | 2302 | 001 | CDER | |||||||||||
|
|
Elusys Therapeutics, Inc. | 125509 | Anthim | obiltoxaximab | 351(a) | 600MG/6ML (100MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 18, 2016 | Original | 1907 | 001 | CDER | March 18, 2023 | ||||||||||
|
|
Emergent BioSolutions Canada Inc. | 125562 | Anthrasil | Anthrax Immune Globulin Intravenous (Human) | 351(a) | >=60 U | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 24, 2015 | 0 | Original | 2084 | 001 | CBER | March 24, 2022 | |||||||||
|
|
Sanofi-Aventis U.S. LLC | 021629 | Apidra | insulin glulisine | 351(a) | 1,000UNITS/10ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Multi-Dose Vial | Rx | Licensed | April 16, 2004 | Original | 1752 | 001 | CDER | |||||||||||
|
|
Sanofi-Aventis U.S. LLC | 021629 | Apidra | insulin glulisine | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Multi-Dose Cartridge | Disc | Licensed | December 20, 2005 | 2 | Supplement | 1752 | 002 | CDER | ||||||||||
|
|
Sanofi-Aventis U.S. LLC | 021629 | Apidra | insulin glulisine | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | February 24, 2009 | 8 | Supplement | 1752 | 003 | CDER | ||||||||||
|
|
Endo Operations Limited | 103782 | Aplisol | Tuberculin, Purified Protein Derivative | 351(a) | 5TU/.1ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | April 20, 1998 | 0 | Original | 2362 | 001 | CBER | ||||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 125039 | Aralast, Aralast Np | Alpha-1-Proteinase Inhibitor (Human) | 351(a) | 0.5G | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 23, 2002 | 0 | Original | 1898 | 001 | CBER | ||||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 125039 | Aralast, Aralast Np | Alpha-1-Proteinase Inhibitor (Human) | 351(a) | 1.0G | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 23, 2002 | 0 | Original | 1898 | 002 | CBER | ||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 25MCG/1ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | September 17, 2001 | Original | 1080 | 001 | CDER | |||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 40MCG/1ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | September 17, 2001 | Original | 1080 | 002 | CDER | |||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 60MCG/1ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | September 17, 2001 | Original | 1080 | 003 | CDER | |||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 100MCG/1ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | September 17, 2001 | Original | 1080 | 004 | CDER | |||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 200MCG/1ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | September 17, 2001 | Original | 1080 | 005 | CDER | |||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 25MCG/1ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | September 17, 2001 | Original | 1080 | 006 | CDER | |||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 40MCG/1ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | September 17, 2001 | Original | 1080 | 007 | CDER | |||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 60MCG/1ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | September 17, 2001 | Original | 1080 | 008 | CDER | |||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 100MCG/1ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | September 17, 2001 | Original | 1080 | 009 | CDER | |||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 200MCG/1ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | September 17, 2001 | Original | 1080 | 010 | CDER | |||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 150MCG/0.75ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | July 19, 2002 | 5001 | Supplement | 1080 | 011 | CDER | ||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 300MCG/1ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | July 19, 2002 | 5001 | Supplement | 1080 | 012 | CDER | ||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 500MCG/1ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | July 19, 2002 | 5001 | Supplement | 1080 | 013 | CDER | ||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 60MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Disc | Licensed | December 17, 2002 | 5022 | Supplement | 1080 | 014 | CDER | ||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 100MCG/0.5ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Disc | Licensed | December 17, 2002 | 5022 | Supplement | 1080 | 015 | CDER | ||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 150MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Disc | Licensed | December 17, 2002 | 5022 | Supplement | 1080 | 016 | CDER | ||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 200MCG/0.4ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Disc | Licensed | December 17, 2002 | 5022 | Supplement | 1080 | 017 | CDER | ||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 300MCG/0.6ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Disc | Licensed | December 17, 2002 | 5022 | Supplement | 1080 | 018 | CDER | ||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 500MCG/1ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Disc | Licensed | December 17, 2002 | 5022 | Supplement | 1080 | 019 | CDER | ||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 25MCG/0.42ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Disc | Licensed | December 12, 2003 | 5055 | Supplement | 1080 | 020 | CDER | ||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 25MCG/0.42ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | December 12, 2003 | 5055 | Supplement | 1080 | 021 | CDER | ||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 40MCG/0.4ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Disc | Licensed | December 12, 2003 | 5055 | Supplement | 1080 | 022 | CDER | ||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 40MCG/0.4ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | December 12, 2003 | 5055 | Supplement | 1080 | 023 | CDER | ||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 60MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | December 12, 2003 | 5055 | Supplement | 1080 | 024 | CDER | ||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 100MCG/0.5ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | December 12, 2003 | 5055 | Supplement | 1080 | 025 | CDER | ||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 150MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | December 12, 2003 | 5055 | Supplement | 1080 | 026 | CDER | ||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 200MCG/0.4ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | December 12, 2003 | 5055 | Supplement | 1080 | 027 | CDER | ||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 300MCG/0.6ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | December 12, 2003 | 5055 | Supplement | 1080 | 028 | CDER | ||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 500MCG/1ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | December 12, 2003 | 5055 | Supplement | 1080 | 029 | CDER | ||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 150MCG/0.75ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | December 12, 2003 | 5055 | Supplement | 1080 | 030 | CDER | ||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 300MCG/1ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | December 12, 2003 | 5055 | Supplement | 1080 | 031 | CDER | ||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 500MCG/1ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | December 12, 2003 | 5055 | Supplement | 1080 | 032 | CDER | ||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 25MCG/0.42ML | Injection | Intravenous, Subcutaneous | Autoinjector | Disc | Licensed | June 29, 2006 | 5113 | Supplement | 1080 | 033 | CDER | ||||||||||
|
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Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 40MCG/0.4ML | Injection | Intravenous, Subcutaneous | Autoinjector | Disc | Licensed | June 29, 2006 | 5113 | Supplement | 1080 | 034 | CDER | ||||||||||
|
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Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 60MCG/0.3ML | Injection | Intravenous, Subcutaneous | Autoinjector | Disc | Licensed | June 29, 2006 | 5113 | Supplement | 1080 | 035 | CDER | ||||||||||
|
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Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 100MCG/0.5ML | Injection | Intravenous, Subcutaneous | Autoinjector | Disc | Licensed | June 29, 2006 | 5113 | Supplement | 1080 | 036 | CDER | ||||||||||
|
|
Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 150MCG/0.3ML | Injection | Intravenous, Subcutaneous | Autoinjector | Disc | Licensed | June 29, 2006 | 5113 | Supplement | 1080 | 037 | CDER | ||||||||||
|
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Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 200MCG/0.4ML | Injection | Intravenous, Subcutaneous | Autoinjector | Disc | Licensed | June 29, 2006 | 5113 | Supplement | 1080 | 038 | CDER | ||||||||||
|
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Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 300MCG/0.6ML | Injection | Intravenous, Subcutaneous | Autoinjector | Disc | Licensed | June 29, 2006 | 5113 | Supplement | 1080 | 039 | CDER | ||||||||||
|
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Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 500MCG/1ML | Injection | Intravenous, Subcutaneous | Autoinjector | Disc | Licensed | June 29, 2006 | 5113 | Supplement | 1080 | 040 | CDER | ||||||||||
|
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Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 25MCG/0.42ML | Injection | Intravenous, Subcutaneous | Autoinjector | Disc | Licensed | June 29, 2006 | 5113 | Supplement | 1080 | 041 | CDER | ||||||||||
|
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Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 40MCG/0.4ML | Injection | Intravenous, Subcutaneous | Autoinjector | Disc | Licensed | June 29, 2006 | 5113 | Supplement | 1080 | 042 | CDER | ||||||||||
|
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Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 60MCG/0.3ML | Injection | Intravenous, Subcutaneous | Autoinjector | Disc | Licensed | June 29, 2006 | 5113 | Supplement | 1080 | 043 | CDER | ||||||||||
|
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Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 100MCG/0.5ML | Injection | Intravenous, Subcutaneous | Autoinjector | Disc | Licensed | June 29, 2006 | 5113 | Supplement | 1080 | 044 | CDER | ||||||||||
|
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Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 150MCG/0.3ML | Injection | Intravenous, Subcutaneous | Autoinjector | Disc | Licensed | June 29, 2006 | 5113 | Supplement | 1080 | 045 | CDER | ||||||||||
|
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Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 200MCG/0.4ML | Injection | Intravenous, Subcutaneous | Autoinjector | Disc | Licensed | June 29, 2006 | 5113 | Supplement | 1080 | 046 | CDER | ||||||||||
|
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Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 300MCG/0.6ML | Injection | Intravenous, Subcutaneous | Autoinjector | Disc | Licensed | June 29, 2006 | 5113 | Supplement | 1080 | 047 | CDER | ||||||||||
|
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Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 500MCG/1ML | Injection | Intravenous, Subcutaneous | Autoinjector | Disc | Licensed | June 29, 2006 | 5113 | Supplement | 1080 | 048 | CDER | ||||||||||
|
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Amgen Inc. | 103951 | Aranesp | darbepoetin alpha | 351(a) | 10MCG/0.4ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | Supplement | 1080 | 049 | CDER | ||||||||||||
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Kiniksa Pharmaceuticals (UK), Ltd. | 125249 | Arcalyst | rilonacept | 351(a) | 220MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | February 27, 2008 | Original | 2236 | 001 | CDER | March 18, 2028 | ||||||||||
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ID Biomedical Corporation of Quebec | 125419 | Arepanrix | Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted | 351(a) | 0.5ML | Injection | Intramuscular | Vial | Disc | Licensed | November 22, 2013 | 0 | Original | 1739 | 001 | CBER | ||||||||||
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GlaxoSmithKline Biologicals | 125775 | Arexvy | Respiratory Syncytial Virus Vaccine, Adjuvanted | 351(a) | 120UG/.5ML | For Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | May 3, 2023 | 0 | Original | 1617 | 001 | CBER | May 3, 2023 | May 3, 2035 | ||||||||
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Lupin Limited (Biotech Division) | 761212 | Armlupeg | pegfilgrastim-unne | 351(k) Biosimilar | 6MG/0.6ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | November 28, 2025 | pegfilgrastim | Neulasta | Original | 2052 | 001 | CDER | |||||||||
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Baxter Healthcare Corporation | 125266 | Artiss | Fibrin Sealant (Human) | 351(a) | 4ML | Solution | Topical | Pre-Filled Syringe | Rx | Licensed | March 19, 2008 | 0 | Original | 0140 | 001 | CBER | ||||||||||
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Baxter Healthcare Corporation | 125266 | Artiss | Fibrin Sealant (Human) | 351(a) | 10ML | Solution | Topical | Pre-Filled Syringe | Rx | Licensed | March 19, 2008 | 0 | Original | 0140 | 002 | CBER | ||||||||||
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Baxter Healthcare Corporation | 125266 | Artiss | Fibrin Sealant (Human) | 351(a) | 2ML | Solution | Topical | Pre-Filled Syringe | Rx | Licensed | March 19, 2008 | 0 | Original | 0140 | 003 | CBER | ||||||||||
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Baxter Healthcare Corporation | 125266 | Artiss | Fibrin Sealant (Human) | 351(a) | 4ML | For Solution | Topical | Single-Dose Vial | Disc | Licensed | March 19, 2008 | 0 | Original | 0140 | 004 | CBER | ||||||||||
|
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Baxter Healthcare Corporation | 125266 | Artiss | Fibrin Sealant (Human) | 351(a) | 10ML | For Solution | Topical | Single-Dose Vial | Disc | Licensed | March 19, 2008 | 0 | Original | 0140 | 005 | CBER | ||||||||||
|
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Baxter Healthcare Corporation | 125266 | Artiss | Fibrin Sealant (Human) | 351(a) | 2ML | For Solution | Topical | Single-Dose Vial | Disc | Licensed | March 19, 2008 | 0 | Original | 0140 | 006 | CBER | ||||||||||
|
|
Novartis Pharmaceuticals Corporation | 125326 | Arzerra | ofatumumab | 351(a) | 100MG/5ML | Injection | Intravenous | Single-Dose Vial | Disc | Licensed | October 26, 2009 | Original | 1244 | 001 | CDER | January 19, 2023 | ||||||||||
|
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Novartis Pharmaceuticals Corporation | 125326 | Arzerra | ofatumumab | 351(a) | 1,000MG/50ML | Injection | Intravenous | Single-Dose Vial | Disc | Licensed | April 1, 2011 | 14 | Supplement | 1244 | 002 | CDER | January 19, 2023 | |||||||||
|
|
ADMA Biologics, Inc. | 125590 | Asceniv | Immune Globulin Intravenous, Human-slra | 351(a) | 5G/50ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 1, 2019 | 0 | Original | 2019 | 001 | CBER | ||||||||||
|
|
Servier Pharmaceuticals LLC | 761102 | Asparlas | calaspargase pegol-mknl | 351(a) | 3,750UNITS/5ML (750UNITS/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 20, 2018 | Original | 2125 | 001 | CDER | February 1, 2001 | ||||||||||
|
|
Pharmacia & Upjohn Company LLC | 103676 | Atgam | Lymphocyte Immune Globulin, Anti-thymocyte Globulin (Equine) | 351(a) | 50MG/ML | Injection | Intravenous | Ampule | Rx | Licensed | December 4, 1996 | 0 | Original | 1216 | 001 | CBER | ||||||||||
|
|
rEVO Biologics, Inc. | 125284 | Atryn | Antithrombin (Recombinant) | 351(a) | 1750IU | For Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | February 6, 2009 | 0 | Original | 1904 | 001 | CBER | February 6, 2016 | |||||||||
|
|
rEVO Biologics, Inc. | 125284 | Atryn | Antithrombin (Recombinant) | 351(a) | 525IU | For Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | April 11, 2014 | 134 | Supplement | 1904 | 002 | CBER | February 6, 2016 | |||||||||
|
|
Merck Sharp & Dohme LLC | 101068 | ATTENUVAX | Measles Virus Vaccine Live | 351(a) | NLT1000U/.5ML | For Injection | Subcutaneous | Vial | Disc | Voluntarily Revoked | March 21, 1963 | 0 | Original | 0002 | 001 | CBER | ||||||||||
|
|
Autolus, Inc. | 125813 | Aucatzyl | Obecabtagene autoleucel | 351(a) | 410 × 10^6CAR+ T CELLS TOTAL; DELIVERED AS A SPLIT DOSE IN 3-5 BAGS ON DAY 1 & 10 | Suspension | Intravenous | Bag | Rx | Licensed | November 8, 2024 | 0 | Original | 2339 | 001 | CBER | November 8, 2024 | November 8, 2036 | November 8, 2031 | |||||||
|
|
Seqirus Inc. | 125692 | Audenz | Influenza A (H5N1) Monovalent Vaccine, Adjuvanted | 351(a) | 7.5HA UG/.5ML | Injection | Intramuscular | Multi-Dose Vial | Disc | Licensed | January 31, 2020 | 0 | Original | 2049 | 001 | CBER | ||||||||||
|
|
Biocon Biologics Inc. | 761436 | Aukelso | denosumab-kyqq | 351(k) Interchangeable | 120MG/1.7ML (70MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | September 16, 2025 | October 29, 2025 | denosumab | Xgeva | Original | 2324 | 002 | CDER | ||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 101447 | Autoplex, Feiba Nf, Feiba Vh | Anti-Inhibitor Coagulant Complex | 351(a) | 1000IU | For Injection | Intravenous | Bottle | Disc | Licensed | December 21, 1979 | 0 | Original | 1898 | 001 | CBER | December 16, 2020 | |||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 101447 | Autoplex, Feiba Nf, Feiba Vh | Anti-Inhibitor Coagulant Complex | 351(a) | 500IU | For Injection | Intravenous | Bottle | Disc | Licensed | December 21, 1979 | 0 | Original | 1898 | 002 | CBER | December 16, 2020 | |||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 101447 | Autoplex, Feiba Nf, Feiba Vh | Anti-Inhibitor Coagulant Complex | 351(a) | 1000U | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 31, 2000 | 1029 | Supplement | 1898 | 003 | CBER | December 16, 2020 | |||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 101447 | Autoplex, Feiba Nf, Feiba Vh | Anti-Inhibitor Coagulant Complex | 351(a) | 500U | For Injection | Intravenous | Bottle | Rx | Licensed | July 31, 2000 | 1029 | Supplement | 1898 | 004 | CBER | December 16, 2020 | |||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 101447 | Autoplex, Feiba Nf, Feiba Vh | Anti-Inhibitor Coagulant Complex | 351(a) | 2500U | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 11, 2005 | 5126 | Supplement | 1898 | 005 | CBER | December 16, 2020 | |||||||||
|
|
Axogen Corporation | 125816 | avance nerve graft | acellular nerve allograft-arwx | 351(a) | 1•LENGTHS: 15 MM, 30 MM, 50 MM, AND 70 MM •DIAMETERS: 1 TO 2 MM, 2 TO 3 MM, 3 | Implant | Implantation | Pouch | Rx | Licensed | December 3, 2025 | 0 | Original | 2340 | 001 | CBER | ||||||||||
|
|
Genentech, Inc. | 125085 | Avastin | bevacizumab | 351(a) | 100MG/4ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 26, 2004 | Original | 1048 | 001 | CDER | May 29, 2027 | Yes | |||||||||
|
|
Genentech, Inc. | 125085 | Avastin | bevacizumab | 351(a) | 400MG/16ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 26, 2004 | Original | 1048 | 002 | CDER | May 29, 2027 | Yes | |||||||||
|
|
Biogen Inc. | 103628 | Avonex | interferon beta-1a | 351(a) | 30MCG | For Injection | Intramuscular | Single-Dose Vial | Disc | Licensed | May 17, 1996 | Original | 1697 | 001 | CDER | May 17, 2003 | ||||||||||
|
|
Biogen Inc. | 103628 | Avonex | interferon beta-1a | 351(a) | 30MCG/0.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | May 28, 2003 | 5021 | Supplement | 1697 | 002 | CDER | May 17, 2003 | |||||||||
|
|
Biogen Inc. | 103628 | Avonex | interferon beta-1a | 351(a) | 30MCG/0.5ML | Injection | Intramuscular | Autoinjector | Rx | Licensed | February 27, 2012 | 5191 | Supplement | 1697 | 003 | CDER | May 17, 2003 | |||||||||
|
|
Amgen Inc. | 761086 | Avsola | infliximab-axxq | 351(k) Biosimilar | 100MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 6, 2019 | infliximab | Remicade | Original | 1080 | 001 | CDER | |||||||||
|
|
CELLTRION, Inc. | 761498 | Avtozma | tocilizumab-anoh | 351(k) Biosimilar | 162MG/0.9ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | January 24, 2025 | tocilizumab | Actemra | Original | 1996 | 002 | CDER | |||||||||
|
|
CELLTRION, Inc. | 761498 | Avtozma | tocilizumab-anoh | 351(k) Interchangeable | 162MG/0.9ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | January 24, 2025 | January 24, 2025 | tocilizumab | Actemra | Original | 1996 | 001 | CDER | 46227 | |||||||
|
|
CELLTRION, Inc. | 761420 | Avtozma | tocilizumab-anoh | 351(k) Interchangeable | 80MG/4ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | January 24, 2025 | January 24, 2025 | tocilizumab | Actemra | Original | 1996 | 001 | CDER | 46227 | |||||||
|
|
CELLTRION, Inc. | 761420 | Avtozma | tocilizumab-anoh | 351(k) Interchangeable | 200MG/10ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | January 24, 2025 | January 24, 2025 | tocilizumab | Actemra | Original | 1996 | 002 | CDER | 46227 | |||||||
|
|
CELLTRION, Inc. | 761420 | Avtozma | tocilizumab-anoh | 351(k) Interchangeable | 400MG/20ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | January 24, 2025 | January 24, 2025 | tocilizumab | Actemra | Original | 1996 | 003 | CDER | 46227 | |||||||
|
|
Bio-Thera Solutions, Ltd. | 761198 | Avzivi | bevacizumab-tnjn | 351(k) Biosimilar | 100MG/4ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 6, 2023 | bevacizumab | Avastin | Original | 2218 | 001 | CDER | |||||||||
|
|
Bio-Thera Solutions, Ltd. | 761198 | Avzivi | bevacizumab-tnjn | 351(k) Biosimilar | 400MG/16ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 6, 2023 | bevacizumab | Avastin | Original | 2218 | 002 | CDER | |||||||||
|
|
California Department of Public Health (CDPH) | 125034 | BabyBig | Botulism Immune Globulin Intravenous (Human) | 351(a) | 100MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 23, 2003 | 0 | Original | 1797 | 001 | CBER | October 23, 2010 | |||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125776 | Balfaxar | Prothrombin complex concentrate, human-lans | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 21, 2023 | 0 | Original | 1646 | 001 | CBER | ||||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125776 | Balfaxar | Prothrombin complex concentrate, human-lans | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 21, 2023 | 0 | Original | 1646 | 002 | CBER | ||||||||||
|
|
Eli Lilly and Company | 205692 | Basaglar | insulin glargine | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Disc | Licensed | December 16, 2015 | Original | 1891 | 001 | CDER | |||||||||||
|
|
Eli Lilly and Company | 205692 | Basaglar | insulin glargine | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | November 15, 2019 | 21 | Supplement | 1891 | 002 | CDER | ||||||||||
|
|
Emergent BioSolutions Canada Inc. | 125462 | Bat | Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) | 351(a) | >4500U | Solution | Intravenous | Single-Dose Vial | Rx | Licensed | March 22, 2013 | 0 | Original | 2084 | 001 | CBER | March 22, 2020 | |||||||||
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EMD Serono, Inc. | 761049 | Bavencio | avelumab | 351(a) | 200MG/10ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 23, 2017 | Original | 1773 | 001 | CDER | March 23, 2024 | ||||||||||
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Grifols Therapeutics LLC | 101134 | Baygam, Gamastan S/D | Immune Globulin (Human) | 351(a) | 16.50% | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | January 11, 1944 | 0 | Original | 1871 | 001 | CBER | ||||||||||
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Grifols Therapeutics LLC | 101146 | Bayhep B, Hyperhep B S/D | Hepatitis B Immune Globulin (Human) | 351(a) | 220U/ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | September 23, 1977 | 0 | Original | 1871 | 001 | CBER | ||||||||||
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Grifols Therapeutics LLC | 101146 | Bayhep B, Hyperhep B S/D | Hepatitis B Immune Globulin (Human) | 351(a) | 220U/ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | September 23, 1977 | 0 | Original | 1871 | 002 | CBER | ||||||||||
|
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Grifols Therapeutics LLC | 101146 | Bayhep B, Hyperhep B S/D | Hepatitis B Immune Globulin (Human) | 351(a) | 220U/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | September 23, 1977 | 0 | Original | 1871 | 003 | CBER | ||||||||||
|
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Grifols Therapeutics LLC | 101146 | Bayhep B, Hyperhep B S/D | Hepatitis B Immune Globulin (Human) | 351(a) | 220U/.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | September 23, 1977 | 0 | Original | 1871 | 004 | CBER | ||||||||||
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Grifols Therapeutics LLC | 101146 | Bayhep B, Hyperhep B S/D | Hepatitis B Immune Globulin (Human) | 351(a) | 220IU/5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | September 23, 1977 | 0 | Original | 1871 | 005 | CBER | ||||||||||
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Grifols Therapeutics LLC | 101144 | Bayrab, Hyperrab | Rabies Immune Globulin (Human) | 351(a) | 300IU/ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | June 12, 1974 | 0 | Original | 1871 | 001 | CBER | ||||||||||
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Grifols Therapeutics LLC | 101144 | Bayrab, Hyperrab | Rabies Immune Globulin (Human) | 351(a) | 1500IU/5 ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | June 12, 1974 | 0 | Original | 1871 | 002 | CBER | ||||||||||
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Grifols Therapeutics LLC | 101144 | Bayrab,Hyperrab | Rabies Immune Globulin (Human) | 351(a) | 900 IU/ 3ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | November 6, 2019 | 5817 | Supplement | 1871 | 003 | CBER | ||||||||||
|
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Grifols Therapeutics LLC | 101141 | Bayrho-D, Hyprho-D, Hyperrho S/D Full Dose, Hyperrho S/D Mini-Dose | Rho(D) Immune Globulin (Human) | 351(a) | 1500IU | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | June 11, 1971 | 0 | Original | 1871 | 001 | CBER | ||||||||||
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Grifols Therapeutics LLC | 101141 | Bayrho-D, Hyprho-D, Hyperrho S/D Full Dose, Hyperrho S/D Mini-Dose | Rho(D) Immune Globulin (Human) | 351(a) | 250IU | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | June 11, 1971 | 0 | Original | 1871 | 002 | CBER | ||||||||||
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Grifols Therapeutics LLC | 101142 | Baytet, Hypertet | Tetanus Immune Globulin (Human) | 351(a) | 250U | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | October 17, 1957 | 0 | Original | 1871 | 001 | CBER | ||||||||||
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Wyeth Pharmaceuticals LLC | 103677 | Benefix | Coagulation Factor IX (Recombinant) | 351(a) | 1000IU/ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 11, 1997 | 0 | Original | 0003 | 001 | CBER | February 11, 2004 | |||||||||
|
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Wyeth Pharmaceuticals LLC | 103677 | Benefix | Coagulation Factor IX (Recombinant) | 351(a) | 500IU/ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 11, 1997 | 0 | Original | 0003 | 002 | CBER | February 11, 2004 | |||||||||
|
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Wyeth Pharmaceuticals LLC | 103677 | Benefix | Coagulation Factor IX (Recombinant) | 351(a) | 250IU/ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 11, 1997 | 0 | Original | 0003 | 003 | CBER | February 11, 2004 | |||||||||
|
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Wyeth Pharmaceuticals LLC | 103677 | Benefix | Coagulation Factor IX (Recombinant) | 351(a) | 2000IU/ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 21, 2007 | 5245 | Supplement | 0003 | 004 | CBER | February 11, 2004 | |||||||||
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Wyeth Pharmaceuticals LLC | 103677 | Benefix | Coagulation Factor IX (Recombinant) | 351(a) | 3000IU/ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 23, 2011 | 6051 | Supplement | 0003 | 005 | CBER | February 11, 2004 | |||||||||
|
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GlaxoSmithKline LLC | 125370 | Benlysta | belimumab | 351(a) | 120MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 9, 2011 | Original | 1727 | 001 | CDER | |||||||||||
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GlaxoSmithKline LLC | 125370 | Benlysta | belimumab | 351(a) | 400MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 9, 2011 | Original | 1727 | 002 | CDER | |||||||||||
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GlaxoSmithKline LLC | 761043 | Benlysta | belimumab | 351(a) | 200MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | July 20, 2017 | Original | 1727 | 001 | CDER | |||||||||||
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GlaxoSmithKline LLC | 761043 | Benlysta | belimumab | 351(a) | 200MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | July 20, 2017 | Original | 1727 | 002 | CDER | |||||||||||
|
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Novartis Pharmaceuticals Corporation | 761125 | Beovu | brolucizumab-dbll | 351(a) | 6MG/0.05ML | Injection | Intravitreal | Single-Dose Vial | Rx | Licensed | October 7, 2019 | Original | 1244 | 001 | CDER | |||||||||||
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Novartis Pharmaceuticals Corporation | 761125 | Beovu | brolucizumab-dbll | 351(a) | 6MG/0.05ML | Injection | Intravitreal | Pre-Filled Syringe | Rx | Licensed | May 27, 2022 | 8 | Supplement | 1244 | 002 | CDER | ||||||||||
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Pfizer Inc. | 125786 | BEQVEZ | fidanacogene elaparvovec-dzkt | 351(a) | 1x E13 VG/ML | Suspension | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | April 25, 2024 | 0 | Original | 2001 | 001 | CBER | April 25, 2024 | April 25, 2036 | April 25, 2031 | |||||||
|
|
CSL Behring GmbH | 125287 | Berinert | C1 Esterase Inhibitor (Human) | 351(a) | 500U | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 9, 2009 | 0 | Original | 1765 | 001 | CBER | October 8, 2016 | |||||||||
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Wyeth Pharmaceuticals LLC | 761040 | Besponsa | inotuzumab ozogamicin | 351(a) | 0.9MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 17, 2017 | Original | 0003 | 001 | CDER | March 6, 2031 | ||||||||||
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PharmaEssentia Corporation | 761166 | Besremi | ropeginterferon alfa-2b-njft | 351(a) | 500MCG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | November 12, 2021 | Original | 2155 | 001 | CDER | November 12, 2028 | ||||||||||
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Bayer HealthCare Pharmaceuticals Inc. | 103471 | Betaseron | interferon beta-1b | 351(a) | 0.3MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | July 23, 1993 | Original | 1778 | 001 | CDER | |||||||||||
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GlaxoSmithKline Biologicals | 125546 | Bexsero | Meningococcal Group B Vaccine | 351(a) | 0.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | January 23, 2015 | 0 | Original | 1617 | 001 | CBER | ||||||||||
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GlaxoSmithKline LLC | 125011 | Bexxar | tositumomab and iodine I-131 tositumomab | 351(a) | 35MG | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | June 27, 2003 | Original | 1727 | 001 | CDER | |||||||||||
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GlaxoSmithKline LLC | 125011 | Bexxar | tositumomab and iodine I-131 tositumomab | 351(a) | 225MG | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | June 27, 2003 | Original | 1727 | 002 | CDER | |||||||||||
|
|
Sanofi Pasteur Inc. | 761328 | Beyfortus | nirsevimab-alip | 351(a) | 50MG/0.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | July 17, 2023 | Original | 1725 | 001 | CDER | |||||||||||
|
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Sanofi Pasteur Inc. | 761328 | Beyfortus | nirsevimab-alip | 351(a) | 100MG/ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | July 17, 2023 | Original | 1725 | 002 | CDER | |||||||||||
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Shanghai Henlius Biotech, Inc. | 761444 | Bildyos | denosumab-nxxp | 351(k) Interchangeable | 60MG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | August 29, 2025 | October 29, 2025 | denosumab | Prolia | Original | 2354 | 001 | CDER | ||||||||
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Shanghai Henlius Biotech, Inc. | 761444 | Bildyos | denosumab-nxxp | 351(k) Interchangeable | 60MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | August 29, 2025 | October 29, 2025 | denosumab | Prolia | Original | 2354 | 002 | CDER | ||||||||
|
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Shanghai Henlius Biotech, Inc. | 761444 | Bilprevda | denosumab-nxxp | 351(k) Interchangeable | 120MG/1.7ML (70MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | August 29, 2025 | October 29, 2025 | denosumab | Xgeva | Original | 2354 | 003 | CDER | ||||||||
|
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UCB, Inc. | 761151 | Bimzelx | bimekizumab-bkzx | 351(a) | 160MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | October 17, 2023 | Original | 1736 | 001 | CDER | |||||||||||
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UCB, Inc. | 761151 | Bimzelx | bimekizumab-bkzx | 351(a) | 160MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | October 17, 2023 | Original | 1736 | 002 | CDER | |||||||||||
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UCB, Inc. | 761151 | Bimzelx | bimekizumab-bkzx | 351(a) | 320MG/2ML (160MG/2ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | October 11, 2024 | 9 | Supplement | 1736 | 003 | CDER | ||||||||||
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UCB, Inc. | 761151 | Bimzelx | bimekizumab-bkzx | 351(a) | 320MG/2ML (160MG/2ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | October 11, 2024 | 9 | Supplement | 1736 | 004 | CDER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 103375 | Bioclate (Armour), Recombinate | Antihemophilic Factor (Recombinant) | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 10, 1992 | 0 | Original | 1898 | 001 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 103375 | Bioclate (Armour), Recombinate | Antihemophilic Factor (Recombinant) | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 10, 1992 | 0 | Original | 1898 | 002 | CBER | ||||||||||
|
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Takeda Pharmaceuticals U.S.A., Inc. | 103375 | Bioclate (Armour), Recombinate | Antihemophilic Factor (Recombinant) | 351(a) | 250IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 10, 1992 | 0 | Original | 1898 | 003 | CBER | ||||||||||
|
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Takeda Pharmaceuticals U.S.A., Inc. | 103375 | Bioclate (Armour), Recombinate | Antihemophilic Factor (Recombinant) | 351(a) | 1500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 10, 2010 | 5313 | Supplement | 1898 | 004 | CBER | ||||||||||
|
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Takeda Pharmaceuticals U.S.A., Inc. | 103375 | Bioclate (Armour), Recombinate | Antihemophilic Factor (Recombinant) | 351(a) | 2000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 10, 2010 | 5313 | Supplement | 1898 | 005 | CBER | ||||||||||
|
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Emergent BioDefense Operations Lansing LLC | 103820 | Biorab | Rabies Vaccine Adsorbed | 351(a) | 1.0ML | Injection | Intramuscular | Vial | Disc | Licensed | November 12, 1998 | 0 | Original | 1755 | 001 | CBER | ||||||||||
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Emergent BioDefense Operations Lansing LLC | 103821 | Biothrax | Anthrax Vaccine Adsorbed | 351(a) | 0.5ML | Injection | Intramuscular | Multi-Dose Vial | Rx | Licensed | November 12, 1998 | 0 | Original | 1755 | 001 | CBER | November 23, 2022 | |||||||||
|
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Emergent BioDefense Operations Lansing LLC | 103821 | Biothrax | Anthrax Vaccine Adsorbed | 351(a) | 0.5ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | November 12, 1998 | 0 | Original | 1755 | 002 | CBER | November 23, 2022 | |||||||||
|
|
ADMA Biologics, Inc. | 125389 | Bivigam | Immune Globulin Intravenous (Human) | 351(a) | 5GM/50ML | Injection | Intravenous | Vial | Rx | Licensed | December 19, 2012 | 0 | Original | 2019 | 001 | CBER | ||||||||||
|
|
ADMA Biologics, Inc. | 125389 | Bivigam | Immune Globulin Intravenous (Human) | 351(a) | 10GM/100ML | Injection | Intravenous | Vial | Rx | Licensed | December 19, 2012 | 0 | Original | 2019 | 002 | CBER | ||||||||||
|
|
Merus NV | 761352 | Bizengri | zenocutuzumab-zbco | 351(a) | 375MG/18.75ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 4, 2024 | Original | 2310 | 001 | CDER | December 4, 2031 | ||||||||||
|
|
Amgen Inc. | 761333 | Bkemv | eculizumab-aeeb | 351(k) Interchangeable | 300MG/30ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 28, 2024 | May 28, 2024 | eculizumab | Soliris | Original | 1080 | 001 | CDER | 45989 | |||||||
|
|
GlaxoSmithKline Intellectual Property Development Ltd. England | 761158 | Blenrep | belantamab mafodotin-blmf | 351(a) | 100MG | For Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | August 5, 2020 | Original | 2148 | 001 | CDER | August 5, 2027 | ||||||||||
|
|
GlaxoSmithKline LLC | 761440 | Blenrep | belantamab mafodotin-blmf | 351(a) | 70MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 23, 2025 | Original | 1727 | 001 | CDER | |||||||||||
|
|
Amgen Inc. | 125557 | Blincyto | blinatumomab | 351(a) | 35MCG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 3, 2014 | Original | 1080 | 001 | CDER | June 14, 2031 | ||||||||||
|
|
Fresenius Kabi USA, LLC | 761398 | Bomyntra | denosumab-bnht | 351(k) Interchangeable | 120MG/1.7ML (70MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | March 25, 2025 | October 29, 2025 | denosumab | Xgeva | Original | 2146 | 002 | CDER | ||||||||
|
|
Fresenius Kabi USA, LLC | 761398 | Bomyntra | denosumab-bnht | 351(k) Interchangeable | 120MG/1.7ML (70MG/ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | March 25, 2025 | October 29, 2025 | denosumab | Xgeva | Original | 2146 | 003 | CDER | ||||||||
|
|
Amneal Pharmaceuticals LLC | 761456 | Boncresa | denosumab-mobz | 351(k) Interchangeable | 60MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | December 19, 2025 | December 19, 2025 | denosumab | Prolia | Original | 2241 | 001 | CDER | ||||||||
|
|
GlaxoSmithKline Biologicals | 125106 | Boostrix | Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed | 351(a) | 2.5LF, 5LF, 2.5UG, 8UG UG/.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | May 3, 2005 | 0 | Original | 1617 | 001 | CBER | ||||||||||
|
|
GlaxoSmithKline Biologicals | 125106 | Boostrix | Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed | 351(a) | 2.5LF, 5LF, 2.5UG, 8UG UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | May 3, 2005 | 0 | Original | 1617 | 002 | CBER | ||||||||||
|
|
Biocon Biologics Inc. | 761436 | Bosaya | denosumab-kyqq | 351(k) Interchangeable | 60MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | September 16, 2025 | October 29, 2025 | denosumab | Prolia | Original | 2324 | 001 | CDER | ||||||||
|
|
AbbVie Inc. | 103000 | Botox | onabotulinumtoxinA | 351(a) | 50UNITS | For Injection | Injection, Intramuscular, Intradermal, Intradetrusor | Single-Dose Vial | Disc | Licensed | December 9, 1991 | Original | 1889 | 003 | CDER | June 20, 2026 | ||||||||||
|
|
AbbVie Inc. | 103000 | Botox | onabotulinumtoxinA | 351(a) | 100UNITS | For Injection | Injection, Intramuscular, Intradermal, Intradetrusor | Single-Dose Vial | Rx | Licensed | December 9, 1991 | Original | 1889 | 004 | CDER | June 20, 2026 | ||||||||||
|
|
AbbVie Inc. | 103000 | Botox | onabotulinumtoxinA | 351(a) | 200UNITS | For Injection | Injection, Intramuscular, Intradermal, Intradetrusor | Single-Dose Vial | Rx | Licensed | December 9, 1991 | Original | 1889 | 005 | CDER | June 20, 2026 | ||||||||||
|
|
AbbVie Inc. | 103000 | Botox Cosmetic | onabotulinumtoxinA | 351(a) | 50UNITS | For Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | December 9, 1991 | Original | 1889 | 001 | CDER | June 20, 2026 | ||||||||||
|
|
AbbVie Inc. | 103000 | Botox Cosmetic | onabotulinumtoxinA | 351(a) | 100UNITS | For Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | December 9, 1991 | Original | 1889 | 002 | CDER | June 20, 2026 | ||||||||||
|
|
Ferring Pharmaceuticals Inc. | 021289 | Bravelle | urofollitropin | 351(a) | 75IU | For Injection | Subcutaneous, Intramuscular | Single-Dose Vial | Disc | Voluntarily Revoked | May 6, 2002 | Original | 2112 | 001 | CDER | |||||||||||
|
|
Juno Therapeutics, Inc. a Bristol Myer-Squibb Company | 125714 | Breyanzi | lisocabtagene maraleucel | 351(a) | 4.6ML/VIAL | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 5, 2021 | 0 | Original | 2156 | 001 | CBER | May 30, 2031 | |||||||||
|
|
BioMarin Pharmaceutical Inc. | 761052 | Brineura | cerliponase alfa | 351(a) | 150MG/5ML (30MG/ML) | Injection | Intraventricular | Single-Dose Vial | Rx | Licensed | April 27, 2017 | Original | 1649 | 001 | CDER | July 24, 2031 | ||||||||||
|
|
TG Therapeutics, Inc. | 761238 | Briumvi | ublituximab-xiiy | 351(a) | 150MG/6ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 28, 2022 | Original | 2090 | 001 | CDER | |||||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 101452 | Buminate, Flexbumin | Albumin (Human) | 351(a) | 20G/100ML | Injection | Intravenous | Bottle | Rx | Licensed | March 3, 1954 | 0 | Original | 1898 | 001 | CBER | ||||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 101452 | Buminate, Flexbumin | Albumin (Human) | 351(a) | 25G/100ML | Injection | Intravenous | Bottle | Rx | Licensed | March 3, 1954 | 0 | Original | 1898 | 002 | CBER | ||||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 101452 | Buminate, Flexbumin | Albumin (Human) | 351(a) | 12.5G/50ML | Injection | Intravenous | Bottle | Rx | Licensed | March 3, 1954 | 0 | Original | 1898 | 003 | CBER | ||||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 101452 | Buminate, Flexbumin | Albumin (Human) | 351(a) | 10G/50ML | Injection | Intravenous | Bottle | Rx | Licensed | March 3, 1954 | 0 | Original | 1898 | 004 | CBER | ||||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 101452 | Buminate, Flexbumin | Albumin (Human) | 351(a) | 12.5G/250ML | Injection | Intravenous | Bottle | Rx | Licensed | March 3, 1954 | 0 | Original | 1898 | 005 | CBER | ||||||||||
|
|
Samsung Bioepis Co., Ltd. | 761202 | Byooviz | ranibizumab-nuna | 351(k) Interchangeable | 10MG/ML | Injection | Intravitreal | Single-Dose Vial | Rx | Licensed | September 17, 2021 | October 3, 2023 | ranibizumab | Lucentis | Original | 6 | 2046 | 001 | CDER | |||||||
|
|
Ablynx NV | 761112 | Cablivi | caplacizumab-yhdp | 351(a) | 11MG | For injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | February 6, 2019 | Original | 2085 | 001 | CDER | February 6, 2026 | ||||||||||
|
|
Genzyme Corporation | 103948 | Campath | alemtuzumab | 351(a) | 30MG (10MG/ML) | Injection | Intravenous | Ampule | Disc | Licensed | May 7, 2001 | Original | 1596 | 001 | CDER | May 7, 2008 | ||||||||||
|
|
Genzyme Corporation | 103948 | Campath | alemtuzumab | 351(a) | 30MG/1ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 12, 2004 | 5034 | Supplement | 1596 | 003 | CDER | May 7, 2008 | |||||||||
|
|
Nielsen Bioscience, Inc | 103257 | Candin | Candida albicans Skin Test Antigen for Cellular Hypersensitivity | 351(a) | 1U/.1ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | November 27, 1995 | 0 | Original | 1903 | 001 | CBER | ||||||||||
|
|
Merck Sharp & Dohme LLC | 125814 | CAPVAXIVE | Pneumococcal 21-valent Conjugate Vaccine | 351(a) | 84UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | June 17, 2024 | 0 | Original | 0002 | 001 | CBER | June 17, 2024 | June 17, 2036 | ||||||||
|
|
CSL Behring AG | 102367 | Carimune, Carimune Nf, Panglobulin, Sandoglobulin | Immune Globulin Intravenous (Human) | 351(a) | 6G | For Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | July 27, 2000 | 1055 | Supplement | 1766 | 001 | CBER | ||||||||||
|
|
CSL Behring AG | 102367 | Carimune, Carimune Nf, Panglobulin, Sandoglobulin | Immune Globulin Intravenous (Human) | 351(a) | 12G | For Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | July 27, 2000 | 1055 | Supplement | 1766 | 002 | CBER | ||||||||||
|
|
CSL Behring AG | 102367 | Carimune, Carimune Nf, Panglobulin, Sandoglobulin | Immune Globulin Intravenous (Human) | 351(a) | 3G | For Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | July 27, 2000 | 1055 | Supplement | 1766 | 003 | CBER | ||||||||||
|
|
Vericel Corporation | 103661 | Carticel Sm Service | Autologous Cultured Chondrocytes | 351(a) | 12MIU/VL | Injection | Implantation | Single-Dose Vial | Disc | Licensed | August 22, 1997 | 0 | Original | 2010 | 001 | CBER | ||||||||||
|
|
Janssen Biotech, Inc. | 125746 | Carvykti | ciltacabtagene autoleucel | 351(a) | 0.5 to 1.0x10^6 chimeric antigen receptor (CAR)-positive viable T cells per kg of body weight, with a maximum dose of 1x10^8 CAR-positive viable T cells in one infusion | For Injection | Intravenous | Bag | Rx | Licensed | February 28, 2022 | 0 | Original | 1864 | 001 | CBER | February 28, 2022 | February 28, 2034 | April 5, 2031 | |||||||
|
|
Vertex Pharmaceuticals Inc | 125787 | Casgevy | Exagamglogene autotemcel | 351(a) | 4-13 × 10^6 CELL/ML | Suspension | Intravenous | Single-Dose Vial | Rx | Licensed | December 8, 2023 | 0 | Original | 2279 | 001 | CBER | January 16, 2031 | |||||||||
|
|
Genentech, Inc. | 103172 | Cathflo Activase | alteplase | 351(a) | 2MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | September 4, 2001 | 5003 | Supplement | 1048 | 003 | CDER | ||||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 125234 | Ceprotin | Protein C Concentrate (Human) | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 30, 2007 | 0 | Original | 1898 | 001 | CBER | March 30, 2014 | |||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 125234 | Ceprotin | Protein C Concentrate (Human) | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 30, 2007 | 0 | Original | 1898 | 002 | CBER | March 30, 2014 | |||||||||
|
|
Genzyme Corporation | 020367 | Cerezyme | imiglucerase | 351(a) | 200UNITS/VIAL | For Injection | Intravenous | Single-Dose Vial | Disc | Licensed | May 23, 1994 | Original | 1596 | 001 | CDER | May 23, 2001 | ||||||||||
|
|
Genzyme Corporation | 020367 | Cerezyme | imiglucerase | 351(a) | 400UNITS/VIAL | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | September 22, 1999 | 34 | Supplement | 1596 | 002 | CDER | May 23, 2001 | |||||||||
|
|
GlaxoSmithKline Biologicals | 125259 | Cervarix | Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant | 351(a) | 0.5ML | Injection | Intramuscular | Pre-Filled Syringe | Disc | Licensed | October 16, 2009 | 0 | Original | 1617 | 001 | CBER | ||||||||||
|
|
Bel-Mar Laboratories, Inc. | 017054 | Chorionic Gonadotropin | chorionic gonadotropin | 351(a) | 5,000UNITS | Injection | Intramuscular | Single-Dose Vial | Disc | Licensed | March 26, 1974 | Original | 2182 | 001 | CDER | |||||||||||
|
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Bel-Mar Laboratories, Inc. | 017054 | Chorionic Gonadotropin | chorionic gonadotropin | 351(a) | 10,000UNITS | Injection | Intramuscular | Single-Dose Vial | Disc | Licensed | March 26, 1974 | Original | 2182 | 002 | CDER | |||||||||||
|
|
Fresenius Kabi USA, LLC | 017067 | Chorionic Gonadotropin | chorionic gonadotropin | 351(a) | 5,000UNITS | For Injection | Intramuscular | Multi-Dose Vial | Disc | Licensed | March 5, 1973 | Original | 2146 | 001 | CDER | |||||||||||
|
|
Fresenius Kabi USA, LLC | 017067 | Chorionic Gonadotropin | chorionic gonadotropin | 351(a) | 10,000UNITS | For Injection | Intramuscular | Multi-Dose Vial | Rx | Licensed | March 5, 1973 | Original | 2146 | 002 | CDER | |||||||||||
|
|
Fresenius Kabi USA, LLC | 017067 | Chorionic Gonadotropin | chorionic gonadotropin | 351(a) | 15,0000UNITS | For Injection | Intramuscular | Multi-Dose Vial | Disc | Licensed | March 5, 1973 | Original | 2146 | 003 | CDER | |||||||||||
|
|
Fresenius Kabi USA, LLC | 017067 | Chorionic Gonadotropin | chorionic gonadotropin | 351(a) | 20,000UNITS | For Injection | Intramuscular | Multi-Dose Vial | Disc | Licensed | March 5, 1973 | Original | 2146 | 004 | CDER | |||||||||||
|
|
Iso-Tex Diagnostics, Inc. | 017835 | Chromalbin | albumin chromated CR-51 serum | 351(a) | 100uCi | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | February 23, 1976 | Original | 2189 | 001 | CDER | |||||||||||
|
|
Iso-Tex Diagnostics, Inc. | 017835 | Chromalbin | albumin chromated CR-51 serum | 351(a) | 250uCi | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | February 23, 1976 | Original | 2189 | 002 | CDER | |||||||||||
|
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Iso-Tex Diagnostics, Inc. | 017835 | Chromalbin | albumin chromated CR-51 serum | 351(a) | 500uCi | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | February 23, 1976 | Original | 2189 | 003 | CDER | |||||||||||
|
|
DisCure Medical, LLC | 018663 | Chymodiactin | chymopapain | 351(a) | 10,000UNITS | For Injection | Intrathecal | Single-Dose Vial | Disc | Licensed | November 10, 1982 | Original | 2185 | 001 | CDER | |||||||||||
|
|
DisCure Medical, LLC | 018663 | Chymodiactin | chymopapain | 351(a) | 4,000UNITS | For Injection | Intrathecal | Single-Dose Vial | Disc | Licensed | August 21, 1984 | 11,12 | Supplement | 2185 | 002 | CDER | ||||||||||
|
|
Sandoz Inc. | 761165 | Cimerli | ranibizumab-eqrn | 351(k) Interchangeable | 10MG/ML (0.5MG/0.05ML) | Injection | Intravitreal | Single-Dose Vial | Rx | Licensed | August 2, 2022 | August 2, 2022 | ranibizumab | Lucentis | Original | 2003 | 001 | CDER | 45202 | |||||||
|
|
Sandoz Inc. | 761165 | Cimerli | ranibizumab-eqrn | 351(k) Interchangeable | 6MG/ML (0.3MG/0.05ML) | Injection | Intravitreal | Single-Dose Vial | Rx | Licensed | August 2, 2022 | August 2, 2022 | ranibizumab | Lucentis | Original | 2003 | 002 | CDER | 45202 | |||||||
|
|
UCB, Inc. | 125160 | Cimzia | certolizumab pegol | 351(a) | 200MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | April 22, 2008 | Original | 1736 | 001 | CDER | |||||||||||
|
|
UCB, Inc. | 125160 | Cimzia | certolizumab pegol | 351(a) | 200MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | March 28, 2019 | 237 | Supplement | 1736 | 002 | CDER | ||||||||||
|
|
Teva Respiratory, LLC | 761033 | Cinqair | reslizumab | 351(a) | 100MG/10ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 23, 2016 | Original | 2047 | 001 | CDER | |||||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 125267 | Cinryze | C1 Esterase Inhibitor (Human) | 351(a) | 500U | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 10, 2008 | 0 | Original | 1898 | 001 | CBER | June 20, 2025 | |||||||||
|
|
Cleveland Cord Blood Center | 125594 | Clevecord | HPC, Cord Blood | 351(a) | 5 x 10^8 TOTAL NUCLEATED CELLS WITH AT LEAST 1.25 x 106 VIABLE CD34+ CELLS | Injection | Intravenous | Bag | Rx | Licensed | September 1, 2016 | 0 | Original | 2026 | 001 | CBER | ||||||||||
|
|
Emergent BioSolutions Canada Inc. | 125109 | Cnj-016 | Vaccinia Immune Globulin Intravenous (Human) | 351(a) | >=50,000U | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 2, 2005 | 0 | Original | 2084 | 001 | CBER | ||||||||||
|
|
Bio Products Laboratory Limited | 125506 | Coagadex | Coagulation Factor X (Human) | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 20, 2015 | 0 | Original | 1811 | 001 | CBER | April 14, 2030 | |||||||||
|
|
Bio Products Laboratory Limited | 125506 | Coagadex | Coagulation Factor X (Human) | 351(a) | 250IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 20, 2015 | 0 | Original | 1811 | 002 | CBER | April 14, 2030 | |||||||||
|
|
Genentech, Inc. | 761309 | Columvi | glofitamab-gxbm | 351(a) | 2.5MG/2.5ML (1MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 15, 2023 | Original | 1048 | 001 | CDER | |||||||||||
|
|
Genentech, Inc. | 761309 | Columvi | glofitamab-gxbm | 351(a) | 10MG/10ML (1MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 15, 2023 | Original | 1048 | 002 | CDER | |||||||||||
|
|
BioNTech Manufacturing GmbH | 125742 | Comirnaty | COVID-19 Vaccine, mRNA | 351(a) | 30UG/0.3ML | For Injection | Intramuscular | Multi-Dose Vial | Disc | Licensed | August 23, 2021 | 0 | Original | 2229 | 001 | CBER | ||||||||||
|
|
BioNTech Manufacturing GmbH | 125742 | Comirnaty | COVID-19 Vaccine, mRNA | 351(a) | 30UG/0.3ML | For Injection | Intramuscular | Multi-Dose Vial | Disc | Licensed | December 16, 2021 | 36 | Supplement | 2229 | 002 | CBER | ||||||||||
|
|
BioNTech Manufacturing GmbH | 125742 | Comirnaty | COVID-19 Vaccine, mRNA | 351(a) | 30UG/0.3ML | For Injection | Intramuscular | Single-Dose Vial | Disc | Licensed | August 25, 2022 | 175 | Supplement | 2229 | 003 | CBER | ||||||||||
|
|
BioNTech Manufacturing GmbH | 125742 | Comirnaty | COVID-19 Vaccine, mRNA | 351(a) | 30UG/0.3ML | For Injection | Intramuscular | Pre-Filled Syringe | Disc | Licensed | August 23, 2023 | 286 | Supplement | 2229 | 004 | CBER | ||||||||||
|
|
BioNTech Manufacturing GmbH | 125742 | Comirnaty | COVID-19 Vaccine, mRNA | 351(a) | 30UG/0.3ML | For Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | October 17, 2023 | 301 | Supplement | 2229 | 005 | CBER | ||||||||||
|
|
BioNTech Manufacturing GmbH | 125742 | Comirnaty | COVID-19 Vaccine, mRNA | 351(a) | 10UG/0.3ML | For Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | August 27, 2025 | 656 | Supplement | 2229 | 006 | CBER | ||||||||||
|
|
Merck Sharp & Dohme LLC | 103623 | COMVAX | Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine | 351(a) | 7.5UG PRP/125UG OMPC/5UG HBsAg | Injection | Intramuscular | Vial | Disc | Voluntarily Revoked | October 2, 1996 | 0 | Original | 0002 | 001 | CBER | ||||||||||
|
|
Fresenius Kabi USA, LLC | 761398 | Conexxence | denosumab-bnht | 351(k) Interchangeable | 60MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | March 25, 2025 | October 29, 2025 | denosumab | Prolia | Original | 2146 | 001 | CDER | ||||||||
|
|
LifeSouth Community Blood Centers, Inc. | 125432 | Cordcyte | HPC, Cord Blood | 351(a) | TOTAL NUCLEATED CELLS CELL/ML | Injection | Intravenous | Bag | Rx | Licensed | June 13, 2013 | 0 | Original | 1647 | 001 | CBER | ||||||||||
|
|
CSL Behring GmbH | 125385 | Corifact | Factor XIII Concentrate (Human) | 351(a) | 1000-1600IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 17, 2011 | 0 | Original | 1765 | 001 | CBER | January 24, 2020 | |||||||||
|
|
Novartis Pharmaceuticals Corporation | 125504 | Cosentyx | secukinumab | 351(a) | 150MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | January 21, 2015 | Original | 1244 | 001 | CDER | |||||||||||
|
|
Novartis Pharmaceuticals Corporation | 125504 | Cosentyx | secukinumab | 351(a) | 150MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | January 21, 2015 | Original | 1244 | 002 | CDER | |||||||||||
|
|
Novartis Pharmaceuticals Corporation | 125504 | Cosentyx | secukinumab | 351(a) | 150MG | For Injection | Subcutaneous | Single-Dose Vial | Disc | Licensed | January 21, 2015 | Original | 1244 | 003 | CDER | |||||||||||
|
|
Novartis Pharmaceuticals Corporation | 125504 | Cosentyx | secukinumab | 351(a) | 75MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | May 28, 2021 | 43 | Supplement | 1244 | 004 | CDER | ||||||||||
|
|
Novartis Pharmaceuticals Corporation | 125504 | Cosentyx | secukinumab | 351(a) | 300MG/2ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | May 11, 2023 | 44 | Supplement | 1244 | 005 | CDER | ||||||||||
|
|
Novartis Pharmaceuticals Corporation | 125504 | Cosentyx | secukinumab | 351(a) | 300MG/2ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | May 11, 2023 | 44 | Supplement | 1244 | 006 | CDER | ||||||||||
|
|
Novartis Pharmaceuticals Corporation | 761349 | Cosentyx | secukinumab | 351(a) | 125MG/5ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 6, 2023 | Original | 1244 | 001 | CDER | |||||||||||
|
|
Organon USA Inc., a subsidiary of Merck & Co., Inc. | 020580 | Cotazym | pancrelipase | 351(a) | 8,000USP UNITS; 30,000USP UNITS; 30,000USP UNITS | Capsule, Delayed Release | Oral | Disc | Voluntarily Revoked | December 9, 1996 | Original | 2193 | 001 | CDER | ||||||||||||
|
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AbbVie Inc. | 020725 | Creon | pancrelipase | 351(a) | 6,000USP UNITS; 19,000USP UNITS; 30,000USP UNITS | Capsule, Delayed Release | Oral | Rx | Licensed | April 30, 2009 | Original | 1889 | 001 | CDER | ||||||||||||
|
|
AbbVie Inc. | 020725 | Creon | pancrelipase | 351(a) | 12,000USP UNITS; 38,000USP UNITS; 60,000USP UNITS | Capsule, Delayed Release | Oral | Rx | Licensed | April 30, 2009 | Original | 1889 | 002 | CDER | ||||||||||||
|
|
AbbVie Inc. | 020725 | Creon | pancrelipase | 351(a) | 24,000USP UNITS; 76,000USP UNITS; 120,000USP UNITS | Capsule, Delayed Release | Oral | Rx | Licensed | April 30, 2009 | Original | 1889 | 003 | CDER | ||||||||||||
|
|
AbbVie Inc. | 020725 | Creon | pancrelipase | 351(a) | 3,000USP UNITS; 9,500USP UNITS; 15,000USP UNITS | Capsule, Delayed Release | Oral | Rx | Licensed | June 10, 2011 | 11 | Supplement | 1889 | 004 | CDER | |||||||||||
|
|
AbbVie Inc. | 020725 | Creon | pancrelipase | 351(a) | 36,000USP UNITS; 114,000USP UNITS; 180,000USP UNITS | Capsule, Delayed Release | Oral | Rx | Licensed | March 14, 2013 | 16 | Supplement | 1889 | 005 | CDER | |||||||||||
|
|
BTG International Inc. | 103788 | Crofab | Crotalidae Polyvalent Immune Fab (Ovine) | 351(a) | 1G | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 2, 2000 | 0 | Original | 1861 | 001 | CBER | October 2, 2007 | |||||||||
|
|
Omrix Biopharmaceuticals Ltd | 125010 | Crosseal, Evicel | Fibrin Sealant (Human) | 351(a) | 5ML | Spray | Topical | Single-Dose Vial | Disc | Voluntarily Revoked | March 21, 2003 | 0 | Original | 1603 | 001 | CBER | ||||||||||
|
|
Omrix Biopharmaceuticals Ltd | 125010 | Crosseal, Evicel | Fibrin Sealant (Human) | 351(a) | 1ML | Spray | Topical | Single-Dose Vial | Disc | Voluntarily Revoked | March 21, 2003 | 0 | Original | 1603 | 002 | CBER | ||||||||||
|
|
Omrix Biopharmaceuticals Ltd | 125010 | Crosseal, Evicel | Fibrin Sealant (Human) | 351(a) | 2ML | Spray | Topical | Single-Dose Vial | Disc | Voluntarily Revoked | March 21, 2003 | 0 | Original | 1603 | 003 | CBER | ||||||||||
|
|
Kyowa Kirin, Inc. | 761068 | Crysvita | burosumab-twza | 351(a) | 10MG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | April 17, 2018 | Original | 2077 | 001 | CDER | September 27, 2026 | ||||||||||
|
|
Kyowa Kirin, Inc. | 761068 | Crysvita | burosumab-twza | 351(a) | 20MG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | April 17, 2018 | Original | 2077 | 002 | CDER | September 27, 2026 | ||||||||||
|
|
Kyowa Kirin, Inc. | 761068 | Crysvita | burosumab-twza | 351(a) | 30MG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | April 17, 2018 | Original | 2077 | 003 | CDER | September 27, 2026 | ||||||||||
|
|
Chiesi USA, Inc. | 020744 | Curosurf | poractant alfa | 351(a) | 120MG/1.5ML (80MG/ML) | Suspension | Intratracheal | Single-Dose Vial | Rx | Licensed | November 18, 1999 | Original | 2150 | 001 | CDER | |||||||||||
|
|
Chiesi USA, Inc. | 020744 | Curosurf | poractant alfa | 351(a) | 240MG/3ML (80MG/ML) | Suspension | Intratracheal | Single-Dose Vial | Rx | Licensed | November 18, 1999 | Original | 2150 | 002 | CDER | |||||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125668 | Cutaquig | Immune Globulin Subcutaneous (Human)-hipp | 351(a) | 1.65G/10 ML | Solution | Subcutaneous | Single-Dose Vial | Rx | Licensed | December 12, 2018 | 0 | Original | 1646 | 001 | CBER | ||||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125668 | Cutaquig | Immune Globulin Subcutaneous (Human)-hipp | 351(a) | 3.3G/20 ML | Solution | Subcutaneous | Single-Dose Vial | Rx | Licensed | December 12, 2018 | 0 | Original | 1646 | 002 | CBER | ||||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125668 | Cutaquig | Immune Globulin Subcutaneous (Human)-hipp | 351(a) | 1G/6ML | Solution | Subcutaneous | Vial | Rx | Licensed | December 12, 2018 | 0 | Original | 1646 | 003 | CBER | ||||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125668 | Cutaquig | Immune Globulin Subcutaneous (Human)-hipp | 351(a) | 2G/12ML | Solution | Subcutaneous | Single-Dose Vial | Rx | Licensed | December 12, 2018 | 0 | Original | 1646 | 004 | CBER | ||||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125668 | Cutaquig | Immune Globulin Subcutaneous (Human)-hipp | 351(a) | 8G/48ML | Solution | Subcutaneous | Single-Dose Vial | Rx | Licensed | December 12, 2018 | 0 | Original | 1646 | 005 | CBER | ||||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125668 | Cutaquig | Immune Globulin Subcutaneous (Human)-hipp | 351(a) | 4G/24ML | Solution | Subcutaneous | Single-Dose Vial | Rx | Licensed | December 12, 2018 | 0 | Original | 1646 | 006 | CBER | ||||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 125596 | Cuvitru | Immune Globulin Subcutaneous (Human), 20% Solution | 351(a) | 1G/5ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | September 13, 2016 | 0 | Original | 1898 | 001 | CBER | ||||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 125596 | Cuvitru | Immune Globulin Subcutaneous (Human), 20% Solution | 351(a) | 2G/10ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | September 13, 2016 | 0 | Original | 1898 | 002 | CBER | ||||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 125596 | Cuvitru | Immune Globulin Subcutaneous (Human), 20% Solution | 351(a) | 8G/40ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | September 13, 2016 | 0 | Original | 1898 | 003 | CBER | ||||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 125596 | Cuvitru | Immune Globulin Subcutaneous (Human), 20% Solution | 351(a) | 4G/20ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | September 13, 2016 | 0 | Original | 1898 | 004 | CBER | ||||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 125596 | Cuvitru | Immune Globulin Subcutaneous (Human), 20% Solution | 351(a) | 10G/50ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | February 7, 2019 | 272 | Supplement | 1898 | 005 | CBER | ||||||||||
|
|
Emergent Product Development Gaithersburg, Inc. | 125761 | CYFENDUS | Anthrax Vaccine Adsorbed, Adjuvanted | 351(a) | 100UG/ML | Injection | Intramuscular | Multi-Dose Vial | Rx | Licensed | July 20, 2023 | 0 | Original | 2089 | 001 | CBER | ||||||||||
|
|
Boehringer Ingelheim Pharmaceuticals, Inc. | 761058 | Cyltezo | adalimumab-adbm | 351(k) Interchangeable | 40MG/0.4ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | April 30, 2024 | May 20, 2025 | adalimumab | Humira | 26 | Supplement | 31 | 2006 | 006 | CDER | ||||||
|
|
Boehringer Ingelheim Pharmaceuticals, Inc. | 761058 | Cyltezo | adalimumab-adbm | 351(k) Interchangeable | 40MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | April 30, 2024 | May 20, 2025 | adalimumab | Humira | 26 | Supplement | 31 | 2006 | 005 | CDER | ||||||
|
|
Boehringer Ingelheim Pharmaceuticals, Inc. | 761058 | Cyltezo | adalimumab-adbm | 351(k) Interchangeable | 40MG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | August 25, 2017 | October 15, 2021 | adalimumab | Humira | Original | 8 | 2006 | 001 | CDER | 45031 | ||||||
|
|
Boehringer Ingelheim Pharmaceuticals, Inc. | 761058 | Cyltezo | adalimumab-adbm | 351(k) Interchangeable | 20MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | July 13, 2018 | October 15, 2021 | adalimumab | Humira | 2 | Supplement | 8 | 2006 | 002 | CDER | 45031 | |||||
|
|
Boehringer Ingelheim Pharmaceuticals, Inc. | 761058 | Cyltezo | adalimumab-adbm | 351(k) Interchangeable | 10MG/0.2ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | March 18, 2022 | March 18, 2022 | adalimumab | Humira | 11 | Supplement | 11 | 2006 | 003 | CDER | 45187 | |||||
|
|
Boehringer Ingelheim Pharmaceuticals, Inc. | 761058 | Cyltezo | adalimumab-adbm | 351(k) Interchangeable | 40MG/0.8ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | May 18, 2023 | October 15, 2021 | adalimumab | Humira | 16 | Supplement | 8 | 2006 | 004 | CDER | 45031 | |||||
|
|
Eli Lilly and Company | 125477 | Cyramza | ramucirumab | 351(a) | 100MG/10ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 21, 2014 | Original | 1891 | 001 | CDER | May 10, 2026 | ||||||||||
|
|
Eli Lilly and Company | 125477 | Cyramza | ramucirumab | 351(a) | 500MG/50ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 21, 2014 | Original | 1891 | 002 | CDER | May 10, 2026 | ||||||||||
|
|
Kamada Ltd. | 103189 | Cytogam | Cytomegalovirus Immune Globulin Intravenous (Human) | 351(a) | 2.5G/50ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 17, 1990 | 0 | Original | 1826 | 001 | CBER | October 4, 2005 | |||||||||
|
|
Y-mABs Therapeutics, Inc | 761171 | Danyelza | naxitamab-gqgk | 351(a) | 40MG/10ML (4MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 25, 2020 | Original | 2209 | 001 | CDER | November 25, 2027 | ||||||||||
|
|
Sanofi Pasteur Limited | 103666 | Daptacel | Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed | 351(a) | 0.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | May 14, 2002 | 0 | Original | 1726 | 001 | CBER | ||||||||||
|
|
Janssen Biotech, Inc. | 761036 | Darzalex | daratumumab | 351(a) | 100MG/5ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 16, 2015 | Original | 1864 | 001 | CDER | September 26, 2026 | ||||||||||
|
|
Janssen Biotech, Inc. | 761036 | Darzalex | daratumumab | 351(a) | 400MG/20ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 16, 2015 | Original | 1864 | 002 | CDER | September 26, 2026 | ||||||||||
|
|
Janssen Biotech, Inc. | 761145 | Darzalex Faspro | daratumumab and hyaluronidase-fihj | 351(a) | 1800MG/15ML; 30,000UNITS/15ML (120MG/2,000UNITS/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | May 1, 2020 | Original | 1864 | 001 | CDER | January 15, 2028 | ||||||||||
|
|
Daiichi Sankyo, Inc | 761394 | Datroway | datopotamab deruxtecan-dlnk | 351(a) | 100MG | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | January 17, 2025 | Original | 2128 | 001 | CDER | |||||||||||
|
|
Revance Therapeutics, Inc. | 761127 | Daxxify | daxibotulinumtoxinA-lanm | 351(a) | 50UNITS | For Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | September 7, 2022 | Original | 2101 | 001 | CDER | |||||||||||
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Revance Therapeutics, Inc. | 761127 | Daxxify | daxibotulinumtoxinA-lanm | 351(a) | 100UNITS | For Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | September 7, 2022 | Original | 2101 | 002 | CDER | |||||||||||
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Sanofi Pasteur Inc. | 125682 | Dengvaxia | Dengue Tetravalent Vaccine, Live | 351(a) | 4.5-6.0 LOG10 CCID50 CCID50: CELL CULTURE INFECTIOUS DOSE 50 | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | May 1, 2019 | 0 | Original | 1725 | 001 | CBER | May 1, 2019 | May 1, 2031 | ||||||||
|
|
Wellcome Foundation Limited Wellcome Research Laboratories | 103141 | Digibind | Digoxin Immune Fab (Ovine) | 351(a) | 38MG | For Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | April 22, 1986 | 0 | Original | 0129 | 001 | CBER | April 22, 1993 | |||||||||
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Salvagenix Inc. | 103910 | Digifab | Digoxin Immune Fab (Ovine) | 351(a) | 40MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 31, 2001 | 0 | Original | 2424 | 001 | CBER | ||||||||||
|
|
Jubilant DraxImage Inc. | 017881 | Draximage MAA | kit for the preparation of technetium Tc-99m albumin aggregated | 351(a) | 2.5MG/5MG/0.6MG/ 1.2MG | For Injectable Suspension | Intravenous | Multi-Dose Vial | Rx | Licensed | December 30, 1987 | Original | 2186 | 001 | CDER | |||||||||||
|
|
Duke University School of Medicine | 125407 | Ducord | HPC, Cord Blood | 351(a) | GREATER THAN OR EQUAL TO 2.5 X 10E7 PER KG CELLS PER KILOGRAM | Injection | Intravenous | Bag | Rx | Licensed | October 4, 2012 | 0 | Original | 1870 | 001 | CBER | ||||||||||
|
|
Regeneron Pharmaceuticals, Inc. | 761055 | Dupixent | dupilumab | 351(a) | 300MG/2ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | March 28, 2017 | Original | 1760 | 001 | CDER | January 25, 2031 | ||||||||||
|
|
Regeneron Pharmaceuticals, Inc. | 761055 | Dupixent | dupilumab | 351(a) | 300MG/2ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | March 28, 2017 | Original | 1760 | 002 | CDER | January 25, 2031 | ||||||||||
|
|
Regeneron Pharmaceuticals, Inc. | 761055 | Dupixent | dupilumab | 351(a) | 200MG/1.14ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | October 19, 2018 | 7 | Supplement | 1760 | 003 | CDER | January 25, 2031 | |||||||||
|
|
Regeneron Pharmaceuticals, Inc. | 761055 | Dupixent | dupilumab | 351(a) | 300MG/2ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | June 18, 2020 | 17 | Supplement | 1760 | 004 | CDER | January 25, 2031 | |||||||||
|
|
Regeneron Pharmaceuticals, Inc. | 761055 | Dupixent | dupilumab | 351(a) | 200MG/1.14ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | June 14, 2021 | 16 | Supplement | 1760 | 005 | CDER | January 25, 2031 | |||||||||
|
|
Regeneron Pharmaceuticals, Inc. | 761055 | Dupixent | dupilumab | 351(a) | 100MG/0.67ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | October 20, 2021 | 31 | Supplement | 1760 | 006 | CDER | January 25, 2031 | |||||||||
|
|
Ipsen Biopharm Limited | 125274 | Dysport | abobotulinumtoxinA | 351(a) | 300UNITS | For Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | April 29, 2009 | Original | 1787 | 001 | CDER | July 29, 2023 | ||||||||||
|
|
Ipsen Biopharm Limited | 125274 | Dysport | abobotulinumtoxinA | 351(a) | 500UNITS | For Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | April 29, 2009 | Original | 1787 | 002 | CDER | July 29, 2023 | ||||||||||
|
|
Emergent Manufacturing Operations Baltimore LLC | 761172 | Ebanga | ansuvimab-zykl | 351(a) | 400MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 21, 2020 | Original | 2083 | 001 | CDER | December 21, 2027 | ||||||||||
|
|
Eli Lilly and Company | 761306 | Ebglyss | lebrikizumab-lbkz | 351(a) | 250MG/2ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | September 13, 2024 | Original | 1891 | 001 | CDER | |||||||||||
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Eli Lilly and Company | 761306 | Ebglyss | lebrikizumab-lbkz | 351(a) | 250MG/2ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | September 13, 2024 | Original | 1891 | 002 | CDER | |||||||||||
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Theratechnologies Inc. | 022505 | Egrifta | tesamorelin | 351(a) | 1MG | For Injection | Subcutaneous | Single-Dose Vial | Disc | Licensed | November 10, 2010 | Original | 2091 | 001 | CDER | |||||||||||
|
|
Theratechnologies Inc. | 022505 | Egrifta SV | tesamorelin | 351(a) | 2MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | November 29, 2011 | 1 | Supplement | 2091 | 002 | CDER | ||||||||||
|
|
Theratechnologies Inc. | 022505 | Egrifta WR | tesamorelin | 351(a) | 11.6MG | For Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 25, 2025 | 20 | Supplement | 2091 | 003 | CDER | ||||||||||
|
|
ImmunoGen, Inc. | 761310 | Elahere | mirvetuximab soravtansine-gynx | 351(a) | 100MG/20ML (5MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 14, 2022 | Original | 2288 | 001 | CDER | November 14, 2029 | ||||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 125151 | Elaprase | idursulfase | 351(a) | 6MG/3ML (2MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 24, 2006 | Original | 1898 | 001 | CDER | July 24, 2013 | ||||||||||
|
|
Parke-Davis, a Division of Pfizer Inc. | 050294 | Elase-chloromycetin | fibrinolysin and desoxyribonuclease combined [bovine], with chloramphenicol | 351(a) | 10MG/GM; 666UNITS/GM; 1UNIT/GM | Ointment | Topical | Tube | Disc | Voluntarily Revoked | April 1, 1964 | Original | 2205 | 001 | CDER | |||||||||||
|
|
Pfizer Inc. | 022458 | Elelyso | taliglucerase alfa | 351(a) | 200UNITS | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 1, 2012 | Original | 2001 | 001 | CDER | |||||||||||
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Sarepta Therapeutics, Inc. | 125781 | ELEVIDYS | delandistrogene moxeparvovec-rokl | 351(a) | 1.33 ×10E14 vector genomes (vg)/kg/bodyweight(bw) | Suspension | Intravenous | Single-Dose Vial | Rx | Licensed | June 22, 2023 | 0 | Original | 2308 | 001 | CBER | June 22, 2023 | June 22, 2035 | June 20, 2031 | |||||||
|
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Chiesi Farmaceutici S.p.A. | 761161 | Elfabrio | pegunigalsidase alfa-iwxj | 351(a) | 20MG/10ML (2MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 9, 2023 | Original | 2245 | 001 | CDER | |||||||||||
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Chiesi Farmaceutici S.p.A. | 761161 | Elfabrio | pegunigalsidase alfa-iwxj | 351(a) | 5MG/2.5ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 17, 2024 | 2 | Supplement | 2245 | 002 | CDER | ||||||||||
|
|
Sanofi-Aventis U.S. LLC | 103946 | Elitek | rasburicase | 351(a) | 1.5MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 12, 2002 | Original | 1752 | 001 | CDER | July 12, 2009 | ||||||||||
|
|
Sanofi-Aventis U.S. LLC | 103946 | Elitek | rasburicase | 351(a) | 7.5MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | January 6, 2006 | 5020 | Supplement | 1752 | 002 | CDER | July 12, 2009 | |||||||||
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|
Bioverativ Therapeutics, Inc. | 125487 | Eloctate | Antihemophilic Factor (Recombinant), Fc Fusion protein | 351(a) | 1500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 6, 2014 | 0 | Original | 2078 | 001 | CBER | June 6, 2021 | |||||||||
|
|
Bioverativ Therapeutics, Inc. | 125487 | Eloctate | Antihemophilic Factor (Recombinant), Fc Fusion protein | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 6, 2014 | 0 | Original | 2078 | 002 | CBER | June 6, 2021 | |||||||||
|
|
Bioverativ Therapeutics, Inc. | 125487 | Eloctate | Antihemophilic Factor (Recombinant), Fc Fusion protein | 351(a) | 2000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 6, 2014 | 0 | Original | 2078 | 003 | CBER | June 6, 2021 | |||||||||
|
|
Bioverativ Therapeutics, Inc. | 125487 | Eloctate | Antihemophilic Factor (Recombinant), Fc Fusion protein | 351(a) | 3000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 6, 2014 | 0 | Original | 2078 | 004 | CBER | June 6, 2021 | |||||||||
|
|
Bioverativ Therapeutics, Inc. | 125487 | Eloctate | Antihemophilic Factor (Recombinant), Fc Fusion protein | 351(a) | 750IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 6, 2014 | 0 | Original | 2078 | 005 | CBER | June 6, 2021 | |||||||||
|
|
Bioverativ Therapeutics, Inc. | 125487 | Eloctate | Antihemophilic Factor (Recombinant), Fc Fusion protein | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 6, 2014 | 0 | Original | 2078 | 006 | CBER | June 6, 2021 | |||||||||
|
|
Bioverativ Therapeutics, Inc. | 125487 | Eloctate | Antihemophilic Factor (Recombinant), Fc Fusion protein | 351(a) | 250IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 6, 2014 | 0 | Original | 2078 | 007 | CBER | June 6, 2021 | |||||||||
|
|
Bioverativ Therapeutics, Inc. | 125487 | Eloctate | Antihemophilic Factor (Recombinant), Fc Fusion protein | 351(a) | 5000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | January 27, 2017 | 450 | Supplement | 2078 | 008 | CBER | June 6, 2021 | |||||||||
|
|
Bioverativ Therapeutics, Inc. | 125487 | Eloctate | Antihemophilic Factor (Recombinant), Fc Fusion protein | 351(a) | 6000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | January 27, 2017 | 450 | Supplement | 2078 | 009 | CBER | June 6, 2021 | |||||||||
|
|
Bioverativ Therapeutics, Inc. | 125487 | Eloctate | Antihemophilic Factor (Recombinant), Fc Fusion protein | 351(a) | 4000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | January 27, 2017 | 450 | Supplement | 2078 | 010 | CBER | June 6, 2021 | |||||||||
|
|
Pfizer Inc. | 761345 | Elrexfio | elranatamab-bcmm | 351(a) | 76MG/1.9ML (40MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | August 14, 2023 | Original | 2001 | 001 | CDER | August 14, 2030 | ||||||||||
|
|
Pfizer Inc. | 761345 | Elrexfio | elranatamab-bcmm | 351(a) | 44MG/1.1ML (40MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | August 14, 2023 | Original | 2001 | 002 | CDER | August 14, 2030 | ||||||||||
|
|
Recordati Rare Diseases, Inc. | 101063 | Elspar | asparaginase | 351(a) | 10,000INTERNATIONAL UNITS | For Injection | Intravenous, Intramuscular | Single-Dose Vial | Disc | Licensed | January 10, 1978 | Original | 1899 | 001 | CDER | |||||||||||
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|
Stemline Therapeutics, Inc. | 761116 | Elzonris | tagraxofusp-erzs | 351(a) | 1,000MCG/1ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 21, 2018 | Original | 2088 | 001 | CDER | December 21, 2025 | ||||||||||
|
|
Eli Lilly and Company | 761063 | Emgality | galcanezumab-gnlm | 351(a) | 120MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | September 27, 2018 | Original | 1891 | 001 | CDER | |||||||||||
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Eli Lilly and Company | 761063 | Emgality | galcanezumab-gnlm | 351(a) | 120MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | September 27, 2018 | Original | 1891 | 002 | CDER | |||||||||||
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Eli Lilly and Company | 761063 | Emgality | galcanezumab-gnlm | 351(a) | 100MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | June 4, 2019 | 3 | Supplement | 1891 | 003 | CDER | ||||||||||
|
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Bristol-Myers Squibb Company | 761035 | Empliciti | elotuzumab | 351(a) | 300MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 30, 2015 | Original | 1713 | 001 | CDER | November 6, 2025 | ||||||||||
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Bristol-Myers Squibb Company | 761035 | Empliciti | elotuzumab | 351(a) | 400MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 30, 2015 | Original | 1713 | 002 | CDER | November 6, 2025 | ||||||||||
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|
AbbVie Inc. | 761384 | Emrelis | telisotuzumab vedotin-tllv | 351(a) | 20MG | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 14, 2025 | Original | 1889 | 001 | CDER | |||||||||||
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AbbVie Inc. | 761384 | Emrelis | telisotuzumab vedotin-tllv | 351(a) | 100MG | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 14, 2025 | Original | 1889 | 002 | CDER | |||||||||||
|
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Immunex Corporation | 103795 | Enbrel | etanercept | 351(a) | 25MG | For Injection | Subcutaneous | Single-Dose Vial | Disc | Licensed | November 2, 1998 | Original | 1132 | 001 | CDER | May 27, 2006 | ||||||||||
|
|
Immunex Corporation | 103795 | Enbrel | etanercept | 351(a) | 25MG | For Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | May 27, 1999 | 1001 | Supplement | 1132 | 002 | CDER | May 27, 2006 | |||||||||
|
|
Immunex Corporation | 103795 | Enbrel | etanercept | 351(a) | 50MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | September 27, 2004 | 5184 | Supplement | 1132 | 003 | CDER | May 27, 2006 | |||||||||
|
|
Immunex Corporation | 103795 | Enbrel | etanercept | 351(a) | 25MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | February 1, 2007 | 5322 | Supplement | 1132 | 004 | CDER | May 27, 2006 | |||||||||
|
|
Immunex Corporation | 103795 | Enbrel | etanercept | 351(a) | 25MG/0.5ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | March 5, 2020 | 5577 | Supplement | 1132 | 007 | CDER | May 27, 2006 | |||||||||
|
|
Immunex Corporation | 103795 | Enbrel | etanercept | 351(a) | 50MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | Supplement | 1132 | 006 | CDER | May 27, 2006 | |||||||||||
|
|
Immunex Corporation | 103795 | Enbrel Mini | etanercept | 351(a) | 50MG/ML | Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | September 14, 2017 | 5556 | Supplement | 1132 | 005 | CDER | May 27, 2006 | |||||||||
|
|
Neurotech Pharmaceuticals Inc. | 125798 | encelto | revakinagene taroretcel-lwey | 351(a) | 200,000-440,000CELLS/IMPLANT | Implant | Implantation | Capsule | Rx | Licensed | March 5, 2025 | 0 | Original | 2321 | 001 | CBER | March 5, 2025 | March 5, 2037 | ||||||||
|
|
Merck Sharp & Dohme LLC | 761432 | Enflonsia | clesrovimab-cfor | 351(a) | 105MG/0.7ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | June 9, 2025 | Original | 0002 | 001 | CDER | |||||||||||
|
|
GlaxoSmithKline Biologicals | 103239 | Engerix-B | Hepatitis B Vaccine (Recombinant) | 351(a) | 20UG/ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | August 28, 1989 | 0 | Original | 1617 | 001 | CBER | ||||||||||
|
|
GlaxoSmithKline Biologicals | 103239 | Engerix-B | Hepatitis B Vaccine (Recombinant) | 351(a) | 20UG/ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | August 28, 1989 | 0 | Original | 1617 | 002 | CBER | ||||||||||
|
|
GlaxoSmithKline Biologicals | 103239 | Engerix-B | Hepatitis B Vaccine (Recombinant) | 351(a) | 10UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | August 28, 1989 | 0 | Original | 1617 | 003 | CBER | ||||||||||
|
|
GlaxoSmithKline Biologicals | 103239 | Engerix-B | Hepatitis B Vaccine (Recombinant) | 351(a) | 10UG/.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | August 28, 1989 | 0 | Original | 1617 | 004 | CBER | ||||||||||
|
|
Daiichi Sankyo, Inc | 761139 | Enhertu | fam-trastuzumab deruxtecan-nxki | 351(a) | 100MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 20, 2019 | Original | 2128 | 001 | CDER | January 15, 2028 | ||||||||||
|
|
Bioverativ Therapeutics, Inc. | 761164 | Enjaymo | sutimlimab-jome | 351(a) | 1,100MG/22ML (50MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 4, 2022 | Original | 2078 | 001 | CDER | February 4, 2029 | ||||||||||
|
|
Hikma Pharmaceuticals USA Inc. | 761439 | Enoby | denosumab-qbde | 351(k) Interchangeable | 60MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | September 26, 2025 | October 29, 2025 | denosumab | Prolia | Original | 2356 | 001 | CDER | ||||||||
|
|
Genentech, Inc. | 761149 | Enspryng | satralizumab-mwge | 351(a) | 120MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | August 14, 2020 | Original | 1048 | 001 | CDER | August 14, 2027 | ||||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 125476 | Entyvio | vedolizumab | 351(a) | 300MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 20, 2014 | Original | 1898 | 001 | CDER | |||||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 761133 | Entyvio | vedolizumab | 351(a) | 108MG/0.68ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | September 27, 2023 | Original | 1898 | 001 | CDER | |||||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 761133 | Entyvio Pen | vedolizumab | 351(a) | 108MG/0.68ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | September 27, 2023 | Original | 1898 | 002 | CDER | |||||||||||
|
|
Sandoz Inc. | 761382 | Enzeevu | aflibercept-abzv | 351(k) Biosimilar | 2MG/0.05ML | Injection | Intravitreal | Single-Dose Vial | Rx | Licensed | August 9, 2024 | aflibercept | Eylea | Original | 2003 | 001 | CDER | |||||||||
|
|
Sandoz Inc. | 761382 | Enzeevu | aflibercept-abzv | 351(k) Biosimilar | 2MG/0.05ML | Injection | Intravitreal | Pre-Filled Syringe | Rx | Licensed | August 9, 2024 | aflibercept | Eylea | Original | 2003 | 002 | CDER | |||||||||
|
|
Genmab US, Inc. | 761324 | Epkinly | epcoritamab-bysp | 351(a) | 4MG/0.8ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | May 19, 2023 | Original | 2293 | 001 | CDER | June 26, 2031 | ||||||||||
|
|
Genmab US, Inc. | 761324 | Epkinly | epcoritamab-bysp | 351(a) | 48MG/0.8ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | May 19, 2023 | Original | 2293 | 002 | CDER | June 26, 2031 | ||||||||||
|
|
Amgen Inc. | 103234 | Epogen/Procrit | epoetin alfa | 351(a) | 10,000UNITS/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | June 1, 1989 | Original | 1080 | 001 | CDER | December 31, 1997 | ||||||||||
|
|
Amgen Inc. | 103234 | Epogen/Procrit | epoetin alfa | 351(a) | 2,000UNITS/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | June 1, 1989 | Original | 1080 | 004 | CDER | December 31, 1997 | ||||||||||
|
|
Amgen Inc. | 103234 | Epogen/Procrit | epoetin alfa | 351(a) | 3,000UNITS/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | June 1, 1989 | Original | 1080 | 005 | CDER | December 31, 1997 | ||||||||||
|
|
Amgen Inc. | 103234 | Epogen/Procrit | epoetin alfa | 351(a) | 4,000UNITS/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | June 1, 1989 | Original | 1080 | 007 | CDER | December 31, 1997 | ||||||||||
|
|
Amgen Inc. | 103234 | Epogen/Procrit | epoetin alfa | 351(a) | 20,000UNITS/2ML (10,000UNITS/ML) | Injection | Intravenous, Subcutaneous | Multi-Dose Vial | Rx | Licensed | Supplement | 1080 | 002 | CDER | December 31, 1997 | |||||||||||
|
|
Amgen Inc. | 103234 | Epogen/Procrit | epoetin alfa | 351(a) | 20,000UNITS/ML | Injection | Intravenous, Subcutaneous | Multi-Dose Vial | Rx | Licensed | Supplement | 1080 | 003 | CDER | December 31, 1997 | |||||||||||
|
|
Samsung Bioepis Co., Ltd. | 761340 | Epysqli | eculizumab-aagh | 351(k) Interchangeable | 300MG/30ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 19, 2024 | November 28, 2025 | eculizumab | Soliris | Original | 2046 | 001 | CDER | ||||||||
|
|
Eli Lilly and Company | 125084 | Erbitux | cetuximab | 351(a) | 100MG/50ML (2MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 12, 2004 | Original | 1827 | 001 | CDER | March 1, 2013 | ||||||||||
|
|
Eli Lilly and Company | 125084 | Erbitux | cetuximab | 351(a) | 200MG/100ML (2MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 28, 2007 | 79 | Supplement | 1827 | 002 | CDER | March 1, 2013 | |||||||||
|
|
Sandoz Inc. | 761042 | Erelzi | etanercept-szzs | 351(k) Biosimilar | 25MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | August 30, 2016 | etanercept | Enbrel | Original | 2003 | 001 | CDER | |||||||||
|
|
Sandoz Inc. | 761042 | Erelzi | etanercept-szzs | 351(k) Biosimilar | 50MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | August 30, 2016 | etanercept | Enbrel | Original | 2003 | 002 | CDER | |||||||||
|
|
Sandoz Inc. | 761042 | Erelzi | etanercept-szzs | 351(k) Biosimilar | 25MG | For Injection | Subcutaneous | Multi-Dose Vial | Disc | Licensed | November 10, 2022 | etanercept | Enbrel | 18 | Supplement | 2003 | 004 | CDER | ||||||||
|
|
Sandoz Inc. | 761042 | Erelzi Sensoready | etanercept-szzs | 351(k) Biosimilar | 50MG/ML | Injection | Subcutaneous | Autoinjector | Disc | Licensed | August 30, 2016 | etanercept | Enbrel | Original | 2003 | 003 | CDER | |||||||||
|
|
Merck Sharp & Dohme LLC | 125690 | Ervebo | Ebola Zaire Vaccine, Live | 351(a) | 1ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | December 19, 2019 | 0 | Original | 0002 | 001 | CBER | December 19, 2019 | December 19, 2031 | ||||||||
|
|
Jazz Pharmaceuticals, Inc. | 125359 | Erwinaze | asparaginase Erwinia chrysanthemi | 351(a) | 10,000INTERNATIONAL UNITS | For Injection | Intravenous, Intramuscular | Single-Dose Vial | Disc | Voluntarily Revoked | November 18, 2011 | Original | 1901 | 001 | CDER | |||||||||||
|
|
Novo Nordisk Inc. | 125671 | Esperoct | Antihemophilic Factor (Recombinant), GlycoPEGylated-exei | 351(a) | 3000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 19, 2019 | 0 | Original | 1261 | 001 | CBER | ||||||||||
|
|
Novo Nordisk Inc. | 125671 | Esperoct | Antihemophilic Factor (Recombinant), GlycoPEGylated-exei | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 19, 2019 | 0 | Original | 1261 | 002 | CBER | ||||||||||
|
|
Novo Nordisk Inc. | 125671 | Esperoct | Antihemophilic Factor (Recombinant), GlycoPEGylated-exei | 351(a) | 2000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 19, 2019 | 0 | Original | 1261 | 003 | CBER | ||||||||||
|
|
Novo Nordisk Inc. | 125671 | Esperoct | Antihemophilic Factor (Recombinant), GlycoPEGylated-exei | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 19, 2019 | 0 | Original | 1261 | 004 | CBER | ||||||||||
|
|
Novo Nordisk Inc. | 125671 | Esperoct | Antihemophilic Factor (Recombinant), GlycoPEGylated-exei | 351(a) | 1500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 19, 2019 | 0 | Original | 1261 | 005 | CBER | ||||||||||
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|
Samsung Bioepis Co., Ltd. | 761066 | Eticovo | etanercept-ykro | 351(k) Biosimilar | 50MG/ML | Injection | Subcutaneous | Autoinjector | Disc | Licensed | May 3, 2024 | etanercept | Enbrel | 1 | Supplement | 2046 | 003 | CDER | ||||||||
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Samsung Bioepis Co., Ltd. | 761066 | Eticovo | etanercept-ykro | 351(k) Interchangeable | 50MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | April 25, 2019 | June 25, 2024 | etanercept | Enbrel | Original | 3 | 2046 | 001 | CDER | Date TBD | ||||||
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Samsung Bioepis Co., Ltd. | 761066 | Eticovo | etanercept-ykro | 351(k) Interchangeable | 25MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | April 25, 2019 | June 25, 2024 | etanercept | Enbrel | Original | 3 | 2046 | 002 | CDER | Date TBD | ||||||
|
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Ethicon, Inc. | 125392 | Evarrest | Fibrin Sealant Patch | 351(a) | 50.3MG FIBRINOGEN&203.2IU THROMBIN/IN^2; 4x4 IN | Patch | Topical | Pouch | Disc | Licensed | December 5, 2012 | 0 | Original | 1879 | 001 | CBER | ||||||||||
|
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Ethicon, Inc. | 125392 | Evarrest | Fibrin Sealant Patch | 351(a) | 55.5MG FIBRINOGEN&241.9IU THROMBIN/IN^2; 4x4 IN | Patch | Topical | Pouch | Disc | Licensed | May 16, 2013 | 8 | Supplement | 1879 | 002 | CBER | ||||||||||
|
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Ethicon, Inc. | 125392 | Evarrest | Fibrin Sealant Patch | 351(a) | 55.5MG FIBRINOGEN&241.9IU THROMBIN/IN^2; 2x4 IN | Patch | Topical | Pouch | Rx | Licensed | May 27, 2014 | 20 | Supplement | 1879 | 003 | CBER | ||||||||||
|
|
Amgen Inc. | 761062 | Evenity | romosozumab-aqqg | 351(a) | 105MG/1.17ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | April 9, 2019 | Original | 1080 | 001 | CDER | |||||||||||
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Omrix Biopharmaceuticals Ltd | 125247 | Evithrom | Thrombin, Topical (Human) | 351(a) | 2ML IU/ML | Solution | Topical | Single-Dose Vial | Disc | Licensed | August 27, 2007 | 0 | Original | 1603 | 001 | CBER | ||||||||||
|
|
Omrix Biopharmaceuticals Ltd | 125247 | Evithrom | Thrombin, Topical (Human) | 351(a) | 20ML IU/ML | Solution | Topical | Single-Dose Vial | Disc | Licensed | August 27, 2007 | 0 | Original | 1603 | 002 | CBER | ||||||||||
|
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Omrix Biopharmaceuticals Ltd | 125247 | Evithrom | Thrombin, Topical (Human) | 351(a) | 5ML IU/ML | Solution | Topical | Single-Dose Vial | Disc | Licensed | August 27, 2007 | 0 | Original | 1603 | 003 | CBER | ||||||||||
|
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Omrix Biopharmaceuticals Ltd | 125247 | Evithrom | Thrombin, Topical (Human) | 351(a) | 1600-2400IU/ML | For Injection | Topical | Single-dose vial | Rx | Licensed | September 17, 2009 | 89 | Supplement | 1603 | 004 | CBER | ||||||||||
|
|
Regeneron Pharmaceuticals, Inc. | 761181 | Evkeeza | evinacumab-dgnb | 351(a) | 345MG/2.3ML (150MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 11, 2021 | Original | 1760 | 001 | CDER | March 21, 2030 | ||||||||||
|
|
Regeneron Pharmaceuticals, Inc. | 761181 | Evkeeza | evinacumab-dgnb | 351(a) | 1,200MG/8ML (150MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 11, 2021 | Original | 1760 | 002 | CDER | March 21, 2030 | ||||||||||
|
|
GlaxoSmithKline LLC | 761458 | Exdensur | depemokimab-ulaa | 351(a) | 100MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | December 16, 2025 | Original | 1727 | 001 | CDER | |||||||||||
|
|
GlaxoSmithKline LLC | 761458 | Exdensur | depemokimab-ulaa | 351(a) | 100MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | December 16, 2025 | Original | 1727 | 002 | CDER | |||||||||||
|
|
Novartis Pharmaceuticals Corporation | 125290 | Extavia | interferon beta-1b | 351(a) | 0.3MG | For Injection | Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | August 14, 2009 | Original | 1244 | 001 | CDER | |||||||||||
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|
CELLTRION, Inc. | 761377 | Eydenzelt | aflibercept-boav | 351(k) Biosimilar | 2MG/0.05ML | Injection | Intravitreal | Single-Dose Vial | Rx | Licensed | October 2, 2025 | aflibercept | Eylea | Original | 1996 | 001 | CDER | |||||||||
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CELLTRION, Inc. | 761377 | Eydenzelt | aflibercept-boav | 351(k) Biosimilar | 2MG/0.05ML | Injection | Intravitreal | Pre-Filled Syringe | Rx | Licensed | October 2, 2025 | aflibercept | Eylea | Original | 1996 | 002 | CDER | |||||||||
|
|
Regeneron Pharmaceuticals, Inc. | 125387 | Eylea | aflibercept | 351(a) | 2MG/0.05ML | Injection | Intravitreal | Single-Dose Vial | Rx | Licensed | November 18, 2011 | Original | 1760 | 001 | CDER | November 18, 2011 | May 18, 2024 | February 8, 2030 | Yes | |||||||
|
|
Regeneron Pharmaceuticals, Inc. | 125387 | Eylea | aflibercept | 351(a) | 2MG/0.05ML | Injection | Intravitreal | Pre-Filled Syringe | Rx | Licensed | August 16, 2018 | 58 | Supplement | 1760 | 002 | CDER | February 8, 2030 | Yes | ||||||||
|
|
Regeneron Pharmaceuticals, Inc. | 761355 | Eylea HD | aflibercept | 351(a) | 8MG/0.07ML | Injection | Intravitreal | Single-Dose Vial | Rx | Licensed | August 18, 2023 | Original | 1760 | 001 | CDER | |||||||||||
|
|
Genzyme Corporation | 103979 | Fabrazyme | agalsidase beta | 351(a) | 35MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 24, 2003 | Original | 1596 | 001 | CDER | March 11, 2028 | ||||||||||
|
|
Genzyme Corporation | 103979 | Fabrazyme | agalsidase beta | 351(a) | 5MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 10, 2003 | 5001 | Supplement | 1596 | 002 | CDER | March 11, 2028 | |||||||||
|
|
AstraZeneca AB | 761070 | Fasenra | benralizumab | 351(a) | 30MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | November 14, 2017 | Original | 2059 | 001 | CDER | September 17, 2031 | ||||||||||
|
|
AstraZeneca AB | 761070 | Fasenra | benralizumab | 351(a) | 30MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | October 3, 2019 | 5 | Supplement | 2059 | 002 | CDER | September 17, 2031 | |||||||||
|
|
AstraZeneca AB | 761070 | Fasenra | benralizumab | 351(a) | 10MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | April 5, 2024 | 20 | Supplement | 2059 | 003 | CDER | September 17, 2031 | |||||||||
|
|
Grifols Therapeutics LLC | 125833 | FESILTY | fibrinogen, human–chmt | 351(a) | 1G/50ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 16, 2025 | 0 | Original | 1871 | 001 | CBER | ||||||||||
|
|
Novo Nordisk Inc. | 208751 | Fiasp | insulin aspart | 351(a) | 1000UNITS/10ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 2017 | Original | 1261 | 001 | CDER | |||||||||||
|
|
Novo Nordisk Inc. | 208751 | Fiasp | insulin aspart | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | September 29, 2017 | Original | 1261 | 002 | CDER | |||||||||||
|
|
Novo Nordisk Inc. | 208751 | Fiasp | insulin aspart | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Multi-Dose Cartridge | Rx | Licensed | September 24, 2018 | 3 | Supplement | 1261 | 003 | CDER | ||||||||||
|
|
Novo Nordisk Inc. | 208751 | Fiasp | insulin aspart | 351(a) | 160UNITS/1.6ML (100UNITS/ML) | Injection | Subcutaneous | Multi-Dose Cartridge | Rx | Licensed | June 21, 2023 | 20 | Supplement | 1261 | 004 | CDER | ||||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125612 | Fibryga | Fibrinogen (Human) | 351(a) | 1G | For Injection | Intravenous | Single-Use Bottle | Rx | Licensed | June 7, 2017 | 0 | Original | 1646 | 001 | CBER | ||||||||||
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Instituto Grifols, S.A. | 125077 | Flebogamma 5%, Flebogamma 5% Dif | Immune Globulin Intravenous (Human) | 351(a) | 0.5G/10ML | Injection | Intravenous | Single-Dose Vial | Disc | Licensed | December 15, 2003 | 0 | Original | 1181 | 001 | CBER | ||||||||||
|
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Instituto Grifols, S.A. | 125077 | Flebogamma 5%, Flebogamma 5% Dif | Immune Globulin Intravenous (Human) | 351(a) | 2.5G/50ML | Injection | Intravenous | Single-Dose Vial | Disc | Licensed | December 15, 2003 | 0 | Original | 1181 | 002 | CBER | ||||||||||
|
|
Instituto Grifols, S.A. | 125077 | Flebogamma 5%, Flebogamma 5% Dif | Immune Globulin Intravenous (Human) | 351(a) | 5G/100ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 15, 2003 | 0 | Original | 1181 | 003 | CBER | ||||||||||
|
|
Instituto Grifols, S.A. | 125077 | Flebogamma 5%, Flebogamma 5% Dif | Immune Globulin Intravenous (Human) | 351(a) | 10G/200ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 15, 2003 | 0 | Original | 1181 | 004 | CBER | ||||||||||
|
|
Instituto Grifols, S.A. | 125077 | Flebogamma 5%, Flebogamma 5% Dif | Immune Globulin Intravenous (Human) | 351(a) | 20G/400ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 21, 2006 | 47 | Supplement | 1181 | 005 | CBER | ||||||||||
|
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Instituto Grifols, S.A. | 125077 | Flebogamma 5%, Flebogamma 5% Dif | Immune Globulin Intravenous (Human) | 351(a) | 5G/50ML | Injection | Intravenous | Single-Dose Vial | Disc | Licensed | July 27, 2010 | 146 | Supplement | 1181 | 006 | CBER | ||||||||||
|
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Instituto Grifols, S.A. | 125077 | Flebogamma 5%, Flebogamma 5% Dif | Immune Globulin Intravenous (Human) | 351(a) | 10G/100ML | Injection | Intravenous | Single-Dose Vial | Disc | Licensed | July 27, 2010 | 146 | Supplement | 1181 | 007 | CBER | ||||||||||
|
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Instituto Grifols, S.A. | 125077 | Flebogamma 5%, Flebogamma 5% Dif | Immune Globulin Intravenous (Human) | 351(a) | 20G/200ML | Injection | Intravenous | Single-Dose Vial | Disc | Licensed | July 27, 2010 | 146 | Supplement | 1181 | 008 | CBER | ||||||||||
|
|
Seqirus Inc. | 125510 | Fluad | Influenza Vaccine, Adjuvanted | 351(a) | 45UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Disc | Licensed | November 24, 2015 | 0 | Original | 2049 | 001 | CBER | ||||||||||
|
|
Seqirus Inc. | 125510 | Fluad,Fluad Quadrivalent | Influenza Vaccine, Adjuvanted | 351(a) | 60UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | February 21, 2020 | 143 | Supplement | 2049 | 002 | CBER | ||||||||||
|
|
GlaxoSmithKline Biologicals | 125127 | Fluarix, Fluarix Quadrivalent | Influenza Vaccine | 351(a) | 45UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | August 31, 2005 | 0 | Original | 1617 | 001 | CBER | ||||||||||
|
|
GlaxoSmithKline Biologicals | 125127 | Fluarix, Fluarix Quadrivalent | Influenza Vaccine | 351(a) | 60UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Disc | Licensed | December 14, 2012 | 513 | Supplement | 1617 | 002 | CBER | ||||||||||
|
|
Protein Sciences Corporation | 125285 | Flublok | Influenza Vaccine | 351(a) | 135UG/.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | January 16, 2013 | 0 | Original | 1795 | 001 | CBER | January 16, 2013 | January 16, 2025 | ||||||||
|
|
Protein Sciences Corporation | 125285 | Flublok | Influenza Vaccine | 351(a) | 180UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | October 7, 2016 | 194 | Supplement | 1795 | 002 | CBER | ||||||||||
|
|
Protein Sciences Corporation | 125285 | Flublok | Influenza Vaccine | 351(a) | 135UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | March 4, 2024 | 580 | Supplement | 1795 | 003 | CBER | ||||||||||
|
|
Seqirus Inc. | 125408 | Flucelvax, Flucelvax Quadrivalent | Influenza Vaccine | 351(a) | 45UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Disc | Voluntarily Revoked | November 20, 2012 | 0 | Original | 2049 | 001 | CBER | ||||||||||
|
|
Seqirus Inc. | 125408 | Flucelvax, Flucelvax Quadrivalent | Influenza Vaccine | 351(a) | 60UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Disc | Licensed | May 23, 2016 | 127 | Supplement | 2049 | 002 | CBER | ||||||||||
|
|
Seqirus Inc. | 125408 | Flucelvax, Flucelvax Quadrivalent | Influenza Vaccine | 351(a) | 60UG/.5ML | Injection | Intramuscular | Multi-Dose Vial | Disc | Licensed | March 3, 2017 | 181 | Supplement | 2049 | 003 | CBER | ||||||||||
|
|
Seqirus Inc. | 125408 | Flucelvax, Flucelvax Quadrivalent | Influenza Vaccine | 351(a) | 45UG/.5ML | Injection | Intramuscular | Multi-Dose Vial | Rx | Licensed | March 4, 2024 | 575 | Supplement | 2049 | 004 | CBER | ||||||||||
|
|
Seqirus Inc. | 125408 | Flucelvax, Flucelvax Quadrivalent | Influenza Vaccine | 351(a) | 45UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | March 4, 2024 | 575 | Supplement | 2049 | 005 | CBER | ||||||||||
|
|
ID Biomedical Corporation of Quebec | 125163 | Flulaval, Flulaval Quadrivalent | Influenza Vaccine | 351(a) | 45UG/.5ML | Injection | Intramuscular | Multi-Dose Vial | Rx | Licensed | October 5, 2006 | 0 | Original | 1739 | 001 | CBER | ||||||||||
|
|
ID Biomedical Corporation of Quebec | 125163 | Flulaval, Flulaval Quadrivalent | Influenza Vaccine | 351(a) | 15UG/.5ML | Injection | Intramuscular | Multi-Dose Vial | Disc | Licensed | November 10, 2009 | 135 | Supplement | 1739 | 002 | CBER | ||||||||||
|
|
ID Biomedical Corporation of Quebec | 125163 | Flulaval, Flulaval Quadrivalent | Influenza Vaccine | 351(a) | 60UG/.5ML | Injection | Intramuscular | Multi-Dose Vial | Disc | Licensed | August 15, 2013 | 253 | Supplement | 1739 | 003 | CBER | ||||||||||
|
|
ID Biomedical Corporation of Quebec | 125163 | Flulaval, Flulaval Quadrivalent | Influenza Vaccine | 351(a) | 45UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | September 27, 2013 | 279 | Supplement | 1739 | 004 | CBER | ||||||||||
|
|
ID Biomedical Corporation of Quebec | 125163 | Flulaval, Flulaval Quadrivalent | Influenza Vaccine | 351(a) | 60UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Disc | Licensed | September 27, 2013 | 279 | Supplement | 1739 | 005 | CBER | ||||||||||
|
|
MedImmune, LLC | 125020 | Flumist, Flumist Quad | Influenza Vaccine Live, Intranasal | 351(a) | 10X6.5-7.5 TCID | Suspension | Nasal | Pump Spray | Rx | Licensed | June 17, 2003 | 0 | Original | 1799 | 001 | CBER | ||||||||||
|
|
MedImmune, LLC | 125020 | Flumist, Flumist Quad | Influenza Vaccine Live, Intranasal | 351(a) | 0.2ML | Suspension | Nasal | Pump Spray | Disc | Licensed | February 29, 2012 | 1668 | Supplement | 1799 | 002 | CBER | ||||||||||
|
|
Seqirus Vaccines Limited | 103837 | Fluvirin | Influenza Virus Vaccine | 351(a) | 15UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Disc | Licensed | November 3, 1998 | 0 | Original | 2055 | 001 | CBER | ||||||||||
|
|
Sanofi Pasteur Inc. | 103914 | Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent | Influenza Virus Vaccine | 351(a) | 45UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | December 9, 1999 | 0 | Original | 1725 | 001 | CBER | ||||||||||
|
|
Sanofi Pasteur Inc. | 103914 | Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent | Influenza Virus Vaccine | 351(a) | 45UG/.5ML | Injection | Intramuscular | Single-Dose Vial | Disc | Licensed | December 9, 1999 | 0 | Original | 1725 | 002 | CBER | ||||||||||
|
|
Sanofi Pasteur Inc. | 103914 | Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent | Influenza Virus Vaccine | 351(a) | 180 UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | December 23, 2009 | 5240 | Supplement | 1725 | 003 | CBER | ||||||||||
|
|
Sanofi Pasteur Inc. | 103914 | Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent | Influenza Virus Vaccine | 351(a) | 27UG/0.1 | Injection | Intradermal | Syringe | Disc | Licensed | May 9, 2011 | 5369 | Supplement | 1725 | 004 | CBER | ||||||||||
|
|
Sanofi Pasteur Inc. | 103914 | Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent | Influenza Virus Vaccine | 351(a) | 60UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | June 7, 2013 | 5574 | Supplement | 1725 | 005 | CBER | ||||||||||
|
|
Sanofi Pasteur Inc. | 103914 | Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent | Influenza Virus Vaccine | 351(a) | 60UG/.5ML | Injection | Intramuscular | Single-Dose Vial | Disc | Licensed | June 7, 2013 | 5574 | Supplement | 1725 | 006 | CBER | ||||||||||
|
|
Sanofi Pasteur Inc. | 103914 | Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent | Influenza Virus Vaccine | 351(a) | 60UG/.5ML | Injection | Intramuscular | Multi-Dose Vial | Rx | Licensed | June 7, 2013 | 5574 | Supplement | 1725 | 007 | CBER | ||||||||||
|
|
Sanofi Pasteur Inc. | 103914 | Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent | Influenza Virus Vaccine | 351(a) | 36UG/.5ML | Injection | Intradermal | Pre-Filled Syringe | Disc | Licensed | December 11, 2014 | 5733 | Supplement | 1725 | 008 | CBER | ||||||||||
|
|
Sanofi Pasteur Inc. | 103914 | Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent | Influenza Virus Vaccine | 351(a) | 240UG/.7ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | November 4, 2019 | 6290 | Supplement | 1725 | 009 | CBER | ||||||||||
|
|
Sanofi Pasteur Inc. | 103914 | Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent | Influenza Virus Vaccine | 351(a) | 45UG/.5ML | Injection | Intramuscular | Multi-Dose Vial | Rx | Licensed | November 4, 2019 | 6792 | Supplement | 1725 | 010 | CBER | ||||||||||
|
|
Organon USA Inc., a subsidiary of Merck & Co., Inc. | 020582 | Follistim | follitropin beta | 351(a) | 75IU | For Injection | Subcutaneous, Intramuscular | Single-Dose Vial | Disc | Voluntarily Revoked | September 29, 1997 | Original | 2193 | 001 | CDER | |||||||||||
|
|
Organon USA Inc., a subsidiary of Merck & Co., Inc. | 020582 | Follistim | follitropin beta | 351(a) | 150IU | For Injection | Subcutaneous, Intramuscular | Single-Dose Vial | Disc | Voluntarily Revoked | September 29, 1997 | Original | 2193 | 002 | CDER | |||||||||||
|
|
Organon USA Inc., a subsidiary of Merck & Co., Inc. | 021273 | Follistim AQ | follitropin beta | 351(a) | 75IU/0.5ML | Injection | Subcutaneous, Intramuscular | Single-Dose Vial | Disc | Voluntarily Revoked | August 26, 2005 | Original | 2193 | 001 | CDER | |||||||||||
|
|
Organon USA Inc., a subsidiary of Merck & Co., Inc. | 021273 | Follistim AQ | follitropin beta | 351(a) | 150IU/0.5ML | Injection | Subcutaneous, Intramuscular | Single-Dose Vial | Disc | Voluntarily Revoked | August 26, 2005 | Original | 2193 | 002 | CDER | |||||||||||
|
|
Organon USA LLC, a subsidiary of Organon & Co. | 021211 | Follistim AQ Cartridge | follitropin beta | 351(a) | 300IU/0.36ML | Injection | Subcutaneous | Multi-Dose Cartridge | Rx | Licensed | March 23, 2004 | Original | 2331 | 001 | CDER | |||||||||||
|
|
Organon USA LLC, a subsidiary of Organon & Co. | 021211 | Follistim AQ Cartridge | follitropin beta | 351(a) | 600IU/0.72ML | Injection | Subcutaneous | Multi-Dose Cartridge | Rx | Licensed | March 23, 2004 | Original | 2331 | 002 | CDER | |||||||||||
|
|
Organon USA LLC, a subsidiary of Organon & Co. | 021211 | Follistim AQ Cartridge | follitropin beta | 351(a) | 175IU/0.21ML | Injection | Subcutaneous | Multi-Dose Cartridge | Disc | Licensed | February 11, 2005 | 2 | Supplement | 2331 | 003 | CDER | ||||||||||
|
|
Organon USA LLC, a subsidiary of Organon & Co. | 021211 | Follistim AQ Cartridge | follitropin beta | 351(a) | 900IU/1.08ML | Injection | Subcutaneous | Multi-Dose Cartridge | Rx | Licensed | February 11, 2005 | 2 | Supplement | 2331 | 004 | CDER | ||||||||||
|
|
Biocon Biologics Inc. | 761075 | Fulphila | pegfilgrastim-jmdb | 351(k) Biosimilar | 6MG/0.6ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | June 4, 2018 | pegfilgrastim | Neulasta | Original | 2324 | 001 | CDER | |||||||||
|
|
Kashiv BioSciences, LLC | 761084 | Fylnetra | pegfilgrastim-pbbk | 351(k) Biosimilar | 6MG/0.6ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | May 26, 2022 | pegfilgrastim | Neulasta | Original | 2131 | 001 | CDER | |||||||||
|
|
Swedish Orphan Biovitrum AB (publ) | 761107 | Gamifant | emapalumab-lzsg | 351(a) | 10MG/2ML (5MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 20, 2018 | Original | 1859 | 001 | CDER | November 20, 2025 | ||||||||||
|
|
Swedish Orphan Biovitrum AB (publ) | 761107 | Gamifant | emapalumab-lzsg | 351(a) | 50MG/10ML (5MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 20, 2018 | Original | 1859 | 002 | CDER | November 20, 2025 | ||||||||||
|
|
Swedish Orphan Biovitrum AB (publ) | 761107 | Gamifant | emapalumab-lzsg | 351(a) | 100MG/20ML (5MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 26, 2020 | 4 | Supplement | 1859 | 003 | CDER | November 20, 2025 | |||||||||
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Swedish Orphan Biovitrum AB (publ) | 761107 | Gamifant | emapalumab-lzsg | 351(a) | 50MG/2ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 7, 2023 | 15 | Supplement | 1859 | 004 | CDER | November 20, 2025 | |||||||||
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Swedish Orphan Biovitrum AB (publ) | 761107 | Gamifant | emapalumab-lzsg | 351(a) | 100MG/4ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 7, 2023 | 15 | Supplement | 1859 | 005 | CDER | November 20, 2025 | |||||||||
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Swedish Orphan Biovitrum AB (publ) | 761107 | Gamifant | emapalumab-lzsg | 351(a) | 250MG/10ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 7, 2023 | 15 | Supplement | 1859 | 006 | CDER | November 20, 2025 | |||||||||
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Grifols Therapeutics LLC | 101147 | Gamimune | Immune Globulin Intravenous (Human) | 351(a) | 5PCT | Injection | Intravenous | Vial | Disc | Voluntarily Revoked | September 11, 1981 | 0 | Original | 1871 | 001 | CBER | ||||||||||
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Grifols Therapeutics LLC | 101147 | Gamimune | Immune Globulin Intravenous (Human) | 351(a) | 10PCT | Injection | Intravenous | Vial | Disc | Voluntarily Revoked | September 11, 1981 | 0 | Original | 1871 | 002 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 125105 | Gammagard Liquid | Immune Globulin Infusion (Human) | 351(a) | 10% MG/ML | Injection | Intravenous, Subcutaneous | Single-Use Bottle | Rx | Licensed | April 27, 2005 | 0 | Original | 1898 | 001 | CBER | June 22, 2019 | |||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 103133 | Gammagard, Gammagard S/D, Iveegam | Immune Globulin Intravenous (Human) | 351(a) | 0.5G | For Injection | Intravenous | Single-Use Bottle | Disc | Licensed | February 18, 1986 | 0 | Original | 1898 | 001 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 103133 | Gammagard, Gammagard S/D, Iveegam | Immune Globulin Intravenous (Human) | 351(a) | 1000MG | For Injection | Intravenous | Single-Use Bottle | Disc | Licensed | February 18, 1986 | 0 | Original | 1898 | 002 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 103133 | Gammagard, Gammagard S/D, Iveegam | Immune Globulin Intravenous (Human) | 351(a) | 2500MG | For Injection | Intravenous | Single-Use Bottle | Disc | Licensed | February 18, 1986 | 0 | Original | 1898 | 003 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 103133 | Gammagard, Gammagard S/D, Iveegam | Immune Globulin Intravenous (Human) | 351(a) | 500MG | For Injection | Intravenous | Single-Use Bottle | Disc | Licensed | February 18, 1986 | 0 | Original | 1898 | 004 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 103133 | Gammagard, Gammagard S/D, Iveegam | Immune Globulin Intravenous (Human) | 351(a) | 5000MG | For Injection | Intravenous | Single-Use Bottle | Disc | Licensed | February 18, 1986 | 0 | Original | 1898 | 005 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 103133 | Gammagard, Gammagard S/D, Iveegam | Immune Globulin Intravenous (Human) | 351(a) | 10G | For Injection | Intravenous | Single-Use Bottle | Rx | Licensed | July 27, 2000 | 1064 | Supplement | 1898 | 006 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 103133 | Gammagard, Gammagard S/D, Iveegam | Immune Globulin Intravenous (Human) | 351(a) | 2.5G | For Injection | Intravenous | Single-Use Bottle | Disc | Licensed | July 27, 2000 | 1064 | Supplement | 1898 | 007 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 103133 | Gammagard, Gammagard S/D, Iveegam | Immune Globulin Intravenous (Human) | 351(a) | 5.0G | For Injection | Intravenous | Single-Use Bottle | Rx | Licensed | July 27, 2000 | 1064 | Supplement | 1898 | 008 | CBER | ||||||||||
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Grifols Therapeutics LLC | 125046 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 2.5G | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | August 27, 2003 | 0 | Original | 1871 | 001 | CBER | September 12, 2015 | |||||||||
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Grifols Therapeutics LLC | 125046 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 5G | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | August 27, 2003 | 0 | Original | 1871 | 002 | CBER | September 12, 2015 | |||||||||
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Grifols Therapeutics LLC | 125046 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 10G | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | August 27, 2003 | 0 | Original | 1871 | 003 | CBER | September 12, 2015 | |||||||||
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Grifols Therapeutics LLC | 125046 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 1G | Injection | Intravenous | Bottle | Rx | Licensed | August 27, 2003 | 0 | Original | 1871 | 004 | CBER | September 12, 2015 | |||||||||
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Grifols Therapeutics LLC | 125046 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 20G | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | August 27, 2003 | 0 | Original | 1871 | 005 | CBER | September 12, 2015 | |||||||||
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Grifols Therapeutics LLC | 125046 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 40G | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | August 27, 2003 | 0 | Original | 1871 | 006 | CBER | September 12, 2015 | |||||||||
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Grifols Therapeutics LLC | 125046 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 2.5G | Injection | Subcutaneous | Single-Use Bottle | Rx | Licensed | August 27, 2003 | 0 | Original | 1871 | 007 | CBER | September 12, 2015 | |||||||||
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Grifols Therapeutics LLC | 125046 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 5G | Injection | Subcutaneous | Single-Use Bottle | Rx | Licensed | August 27, 2003 | 0 | Original | 1871 | 008 | CBER | September 12, 2015 | |||||||||
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Grifols Therapeutics LLC | 125046 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 10G | Injection | Subcutaneous | Single-Use Bottle | Rx | Licensed | August 27, 2003 | 0 | Original | 1871 | 009 | CBER | September 12, 2015 | |||||||||
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Grifols Therapeutics LLC | 125046 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 20G | Injection | Subcutaneous | Single-Use Bottle | Rx | Licensed | August 27, 2003 | 0 | Original | 1871 | 010 | CBER | September 12, 2015 | |||||||||
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Grifols Therapeutics LLC | 125046 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 40G | Injection | Subcutaneous | Single-Use Bottle | Rx | Licensed | August 27, 2003 | 0 | Original | 1871 | 011 | CBER | September 12, 2015 | |||||||||
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Bio Products Laboratory Limited | 125329 | Gammaplex | Immune Globulin Intravenous (Human) | 351(a) | 10G/200ML | Injection | Intravenous | Single-Dose Vial | Disc | Licensed | September 17, 2009 | 0 | Original | 1811 | 001 | CBER | ||||||||||
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Bio Products Laboratory Limited | 125329 | Gammaplex | Immune Globulin Intravenous (Human) | 351(a) | 2.5G/50ML | Injection | Intravenous | Single-Dose Vial | Disc | Licensed | September 17, 2009 | 0 | Original | 1811 | 002 | CBER | ||||||||||
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Bio Products Laboratory Limited | 125329 | Gammaplex | Immune Globulin Intravenous (Human) | 351(a) | 5G/100ML | Injection | Intravenous | Single-Dose Vial | Disc | Licensed | September 17, 2009 | 0 | Original | 1811 | 003 | CBER | ||||||||||
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Bio Products Laboratory Limited | 125329 | Gammaplex | Immune Globulin Intravenous (Human) | 351(a) | 20G/400ML | Injection | Intravenous | Single-Dose Vial | Disc | Licensed | February 7, 2014 | 85 | Supplement | 1811 | 004 | CBER | ||||||||||
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Bio Products Laboratory Limited | 125329 | Gammaplex | Immune Globulin Intravenous (Human) | 351(a) | 5G/50ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 6, 2017 | 151 | Supplement | 1811 | 005 | CBER | ||||||||||
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Bio Products Laboratory Limited | 125329 | Gammaplex | Immune Globulin Intravenous (Human) | 351(a) | 10G/100ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 6, 2017 | 151 | Supplement | 1811 | 006 | CBER | ||||||||||
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Bio Products Laboratory Limited | 125329 | Gammaplex | Immune Globulin Intravenous (Human) | 351(a) | 20G/200ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 6, 2017 | 151 | Supplement | 1811 | 007 | CBER | ||||||||||
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CSL Behring LLC | 103956 | gammar i.v.,gammar-p i.v. | Immune Globulin Intravenous (Human) | 351(a) | 10G | For Injection | Intravenous | Vial | Disc | Voluntarily Revoked | March 17, 2000 | 0 | Original | 1767 | 001 | CBER | ||||||||||
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CSL Behring LLC | 103956 | gammar i.v.,gammar-p i.v. | Immune Globulin Intravenous (Human) | 351(a) | 5G | For Injection | Intravenous | Vial | Disc | Voluntarily Revoked | March 17, 2000 | 0 | Original | 1767 | 002 | CBER | ||||||||||
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CSL Behring LLC | 103956 | gammar i.v.,gammar-p i.v. | Immune Globulin Intravenous (Human) | 351(a) | 2.5G | For Injection | Intravenous | Vial | Disc | Voluntarily Revoked | March 17, 2000 | 0 | Original | 1767 | 003 | CBER | ||||||||||
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CSL Behring LLC | 103956 | gammar i.v.,gammar-p i.v. | Immune Globulin Intravenous (Human) | 351(a) | 1G | For Injection | Intravenous | Vial | Disc | Voluntarily Revoked | March 17, 2000 | 0 | Original | 1767 | 004 | CBER | ||||||||||
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Merck Sharp & Dohme LLC | 125126 | Gardasil | Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant | 351(a) | 120MCG L1 PROTEIN FROM HPV 6, 11, 16 AND 18 UG/.5ML | Injection | Intramuscular | Syringe | Disc | Licensed | June 8, 2006 | 0 | Original | 0002 | 001 | CBER | ||||||||||
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Merck Sharp & Dohme LLC | 125508 | Gardasil 9 | Human Papillomavirus 9-valent Vaccine, Recombinant | 351(a) | 0.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | December 10, 2014 | 0 | Original | 0002 | 001 | CBER | ||||||||||
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Merck Sharp & Dohme LLC | 125508 | Gardasil 9 | Human Papillomavirus 9-valent Vaccine, Recombinant | 351(a) | 0.5ML | Injection | Intramuscular | Single-dose vial | Rx | Licensed | December 10, 2014 | 0 | Original | 0002 | 002 | CBER | ||||||||||
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Genentech, Inc. | 125486 | Gazyva | obinutuzumab | 351(a) | 1,000MG/40ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 1, 2013 | Original | 1048 | 001 | CDER | November 16, 2024 | ||||||||||
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Pharmacia & Upjohn Company LLC | 020280 | Genotropin | somatropin | 351(a) | 1.5MG | For Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | August 24, 1995 | Original | 1216 | 001 | CDER | July 25, 2008 | ||||||||||
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Pharmacia & Upjohn Company LLC | 020280 | Genotropin | somatropin | 351(a) | 5MG | For Injection | Subcutaneous | Multi-Dose Cartridge | Rx | Licensed | August 24, 1995 | Original | 1216 | 002 | CDER | July 25, 2008 | ||||||||||
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Pharmacia & Upjohn Company LLC | 020280 | Genotropin | somatropin | 351(a) | 12MG | For Injection | Subcutaneous | Multi-Dose Cartridge | Rx | Licensed | October 23, 1996 | 7 | Supplement | 1216 | 007 | CDER | July 25, 2008 | |||||||||
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Pharmacia & Upjohn Company LLC | 020280 | Genotropin | somatropin | 351(a) | 0.2MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | January 27, 1998 | 9 | Supplement | 1216 | 004 | CDER | July 25, 2008 | |||||||||
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Pharmacia & Upjohn Company LLC | 020280 | Genotropin | somatropin | 351(a) | 0.4MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | January 27, 1998 | 9 | Supplement | 1216 | 006 | CDER | July 25, 2008 | |||||||||
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Pharmacia & Upjohn Company LLC | 020280 | Genotropin | somatropin | 351(a) | 0.6MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | January 27, 1998 | 9 | Supplement | 1216 | 003 | CDER | July 25, 2008 | |||||||||
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Pharmacia & Upjohn Company LLC | 020280 | Genotropin | somatropin | 351(a) | 0.8MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | January 27, 1998 | 9 | Supplement | 1216 | 005 | CDER | July 25, 2008 | |||||||||
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Pharmacia & Upjohn Company LLC | 020280 | Genotropin | somatropin | 351(a) | 1MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | January 27, 1998 | 9 | Supplement | 1216 | 008 | CDER | July 25, 2008 | |||||||||
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Pharmacia & Upjohn Company LLC | 020280 | Genotropin | somatropin | 351(a) | 1.2MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | January 27, 1998 | 9 | Supplement | 1216 | 009 | CDER | July 25, 2008 | |||||||||
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Pharmacia & Upjohn Company LLC | 020280 | Genotropin | somatropin | 351(a) | 1.4MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | January 27, 1998 | 9 | Supplement | 1216 | 010 | CDER | July 25, 2008 | |||||||||
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Pharmacia & Upjohn Company LLC | 020280 | Genotropin | somatropin | 351(a) | 1.6MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | January 27, 1998 | 9 | Supplement | 1216 | 011 | CDER | July 25, 2008 | |||||||||
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Pharmacia & Upjohn Company LLC | 020280 | Genotropin | somatropin | 351(a) | 1.8MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | January 27, 1998 | 9 | Supplement | 1216 | 012 | CDER | July 25, 2008 | |||||||||
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Pharmacia & Upjohn Company LLC | 020280 | Genotropin | somatropin | 351(a) | 2MG | For Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | January 27, 1998 | 9 | Supplement | 1216 | 013 | CDER | July 25, 2008 | |||||||||
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Organogenesis, Inc. | 125400 | Gintuit | Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen | 351(a) | >0.000001UG/ML | Cellular Sheet | Topical | Bag | Disc | Licensed | March 9, 2012 | 0 | Original | 1863 | 001 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 125325 | Glassia | Alpha-1-Proteinase Inhibitor (Human) | 351(a) | 1G | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 1, 2010 | 0 | Original | 1898 | 001 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 125325 | Glassia | Alpha-1-Proteinase Inhibitor (Human) | 351(a) | 4G | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 27, 2025 | 685 | Supplement | 1898 | 002 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 125325 | Glassia | Alpha-1-Proteinase Inhibitor (Human) | 351(a) | 5G | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 27, 2025 | 685 | Supplement | 1898 | 003 | CBER | ||||||||||
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EMD Serono, Inc. | 020378 | Gonal-f | follitropin alfa | 351(a) | 75IU | For Injection | Subcutaneous | Ampule | Disc | Licensed | September 29, 1997 | Original | 1773 | 001 | CDER | May 24, 2007 | ||||||||||
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EMD Serono, Inc. | 020378 | Gonal-f | follitropin alfa | 351(a) | 150IU | For Injection | Subcutaneous | Ampule | Disc | Licensed | September 29, 1997 | Original | 1773 | 002 | CDER | May 24, 2007 | ||||||||||
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EMD Serono, Inc. | 020378 | Gonal-f | follitropin alfa | 351(a) | 1,050IU (600IU/ML) | For Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | February 28, 2001 | 9 | Supplement | 1773 | 004 | CDER | May 24, 2007 | |||||||||
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EMD Serono, Inc. | 020378 | Gonal-f | follitropin alfa | 351(a) | 37.5IU | For Injection | Subcutaneous | Ampule | Disc | Licensed | March 25, 2004 | 15 | Supplement | 1773 | 003 | CDER | May 24, 2007 | |||||||||
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EMD Serono, Inc. | 020378 | Gonal-f | follitropin alfa | 351(a) | 450IU (600IU/ML) | For Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 26, 2004 | 16 | Supplement | 1773 | 005 | CDER | May 24, 2007 | |||||||||
|
|
EMD Serono, Inc. | 021765 | Gonal-f RFF | follitropin alfa | 351(a) | 37.5IU | For Injection | Subcutaneous | Single-Dose Vial | Disc | Licensed | March 25, 2004 | Original | 1773 | 001 | CDER | |||||||||||
|
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EMD Serono, Inc. | 021765 | Gonal-f RFF | follitropin alfa | 351(a) | 75IU | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | March 25, 2004 | Original | 1773 | 002 | CDER | |||||||||||
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EMD Serono, Inc. | 021765 | Gonal-f RFF | follitropin alfa | 351(a) | 150IU | For Injection | Subcutaneous | Single-Dose Vial | Disc | Licensed | March 25, 2004 | Original | 1773 | 003 | CDER | |||||||||||
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EMD Serono, Inc. | 021684 | Gonal-f RFF RediJect | follitropin alfa | 351(a) | 300IU/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | May 25, 2004 | Original | 1773 | 001 | CDER | |||||||||||
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EMD Serono, Inc. | 021684 | Gonal-f RFF RediJect | follitropin alfa | 351(a) | 450IU/0.75ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | May 25, 2004 | Original | 1773 | 002 | CDER | |||||||||||
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EMD Serono, Inc. | 021684 | Gonal-f RFF RediJect | follitropin alfa | 351(a) | 900IU/1.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | May 25, 2004 | Original | 1773 | 003 | CDER | |||||||||||
|
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UAB Teva Baltics | 125294 | Granix | tbo-filgrastim | 351(a) | 300MCG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | August 29, 2012 | Original | 1803 | 001 | CDER | August 29, 2012 | February 29, 2024 | |||||||||
|
|
UAB Teva Baltics | 125294 | Granix | tbo-filgrastim | 351(a) | 480MCG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | August 29, 2012 | Original | 1803 | 002 | CDER | August 29, 2012 | February 29, 2024 | |||||||||
|
|
UAB Teva Baltics | 125294 | Granix | tbo-filgrastim | 351(a) | 300MCG/1ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | July 31, 2018 | 45 | Supplement | 1803 | 003 | CDER | ||||||||||
|
|
UAB Teva Baltics | 125294 | Granix | tbo-filgrastim | 351(a) | 480MCG/1.6ML | Injection | Subcutaneous | Single-Dose Vial | Disc | Licensed | July 31, 2018 | 45 | Supplement | 1803 | 004 | CDER | ||||||||||
|
|
ALK - Abello A/S | 125473 | Grastek | Timothy Grass Pollen Allergen Extract | 351(a) | 2800BAU/TABLET | Tablet | Sublingual | Blister Pack | Rx | Licensed | April 11, 2014 | 0 | Original | 1292 | 001 | CBER | ||||||||||
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Samsung Bioepis Co., Ltd. | 761059 | Hadlima | adalimumab-bwwd | 351(k) Interchangeable | 40MG/0.8ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | July 23, 2019 | May 20, 2025 | adalimumab | Humira | Original | 25 | 2046 | 001 | CDER | |||||||
|
|
Samsung Bioepis Co., Ltd. | 761059 | Hadlima | adalimumab-bwwd | 351(k) Interchangeable | 40MG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | July 23, 2019 | June 28, 2024 | adalimumab | Humira | Original | 18 | 2046 | 002 | CDER | |||||||
|
|
Samsung Bioepis Co., Ltd. | 761059 | Hadlima | adalimumab-bwwd | 351(k) Interchangeable | 40MG/0.8ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | June 17, 2022 | June 28, 2024 | adalimumab | Humira | 4 | Supplement | 18 | 2046 | 003 | CDER | ||||||
|
|
Samsung Bioepis Co., Ltd. | 761059 | Hadlima | adalimumab-bwwd | 351(k) Interchangeable | 40MG/0.4ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | August 15, 2022 | May 20, 2025 | adalimumab | Humira | 5 | Supplement | 25 | 2046 | 004 | CDER | ||||||
|
|
Samsung Bioepis Co., Ltd. | 761059 | Hadlima | adalimumab-bwwd | 351(k) Interchangeable | 40MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | August 15, 2022 | May 20, 2025 | adalimumab | Humira | 5 | Supplement | 25 | 2046 | 005 | CDER | ||||||
|
|
CSL Behring GmbH | 125606 | Haegarda | C1 Esterase Inhibitor Subcutaneous (Human) | 351(a) | 2000IU | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | June 22, 2017 | 0 | Original | 1765 | 001 | CBER | June 22, 2024 | |||||||||
|
|
CSL Behring GmbH | 125606 | Haegarda | C1 Esterase Inhibitor Subcutaneous (Human) | 351(a) | 3000IU | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | June 22, 2017 | 0 | Original | 1765 | 002 | CBER | June 22, 2024 | |||||||||
|
|
GlaxoSmithKline Biologicals | 103475 | Havrix | Hepatitis A Vaccine | 351(a) | 720ELISA U/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | February 22, 1995 | 0 | Original | 1617 | 001 | CBER | ||||||||||
|
|
GlaxoSmithKline Biologicals | 103475 | Havrix | Hepatitis A Vaccine | 351(a) | 720ELISA U/.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | February 22, 1995 | 0 | Original | 1617 | 002 | CBER | ||||||||||
|
|
GlaxoSmithKline Biologicals | 103475 | Havrix | Hepatitis A Vaccine | 351(a) | 1440ELISA U/ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | February 22, 1995 | 0 | Original | 1617 | 003 | CBER | ||||||||||
|
|
GlaxoSmithKline Biologicals | 103475 | Havrix | Hepatitis A Vaccine | 351(a) | 1440ELISA U/ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | February 22, 1995 | 0 | Original | 1617 | 004 | CBER | ||||||||||
|
|
Bayer HealthCare LLC | 103332 | Helixate Fs, Kogenate, Kogenate Fs | Antihemophilic Factor (Recombinant) | 351(a) | 250IU | For Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | August 20, 2002 | 5000 | Supplement | 0008 | 001 | CBER | February 25, 2000 | |||||||||
|
|
Bayer HealthCare LLC | 103332 | Helixate Fs, Kogenate, Kogenate Fs | Antihemophilic Factor (Recombinant) | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | August 20, 2002 | 5000 | Supplement | 0008 | 002 | CBER | February 25, 2000 | |||||||||
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Bayer HealthCare LLC | 103332 | Helixate Fs, Kogenate, Kogenate Fs | Antihemophilic Factor (Recombinant) | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | August 20, 2002 | 5000 | Supplement | 0008 | 003 | CBER | February 25, 2000 | |||||||||
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Bayer HealthCare LLC | 103332 | Helixate Fs, Kogenate, Kogenate Fs | Antihemophilic Factor (Recombinant) | 351(a) | 2000IU | For Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | June 7, 2007 | 5672 | Supplement | 0008 | 004 | CBER | February 25, 2000 | |||||||||
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Bayer HealthCare LLC | 103332 | Helixate Fs, Kogenate, Kogenate Fs | Antihemophilic Factor (Recombinant) | 351(a) | 3000IU | For Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | July 31, 2009 | 5987 | Supplement | 0008 | 005 | CBER | February 25, 2000 | |||||||||
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New York Blood Center, Inc. | 125397 | Hemacord | Hematopoietic Progenitor Cells, Cord (HPC-C) | 351(a) | 5 X 10E8 TOTAL NUCLEATED CELLS WITH AT LEAST 1.25 X 10E6 VIABLE CD34+ CELLS U | Injection | Intravenous | Bag | Rx | Licensed | November 10, 2011 | 0 | Original | 0465 | 001 | CBER | ||||||||||
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CSL Behring LLC | 125772 | Hemgenix | etranacogene dezaparvovec-drlb | 351(a) | 1X10E13GENOME COPIES/ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 22, 2022 | 0 | Original | 1767 | 001 | CBER | November 22, 2022 | November 22, 2034 | November 22, 2029 | |||||||
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Genentech, Inc. | 761083 | Hemlibra | emicizumab-kxwh | 351(a) | 30MG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | November 16, 2017 | Original | 1048 | 001 | CDER | October 4, 2025 | ||||||||||
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Genentech, Inc. | 761083 | Hemlibra | emicizumab-kxwh | 351(a) | 60MG/0.4ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | November 16, 2017 | Original | 1048 | 002 | CDER | October 4, 2025 | ||||||||||
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Genentech, Inc. | 761083 | Hemlibra | emicizumab-kxwh | 351(a) | 105MG/0.7ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | November 16, 2017 | Original | 1048 | 003 | CDER | October 4, 2025 | ||||||||||
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Genentech, Inc. | 761083 | Hemlibra | emicizumab-kxwh | 351(a) | 150MG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | November 16, 2017 | Original | 1048 | 004 | CDER | October 4, 2025 | ||||||||||
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Genentech, Inc. | 761083 | Hemlibra | emicizumab-kxwh | 351(a) | 300MG/2ML (150MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | March 16, 2023 | 17 | Supplement | 1048 | 005 | CDER | October 4, 2025 | |||||||||
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Genentech, Inc. | 761083 | Hemlibra | emicizumab-kxwh | 351(a) | 12MG/0.4ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | January 31, 2024 | 18 | Supplement | 1048 | 006 | CDER | October 4, 2025 | |||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 101448 | Hemofil M | Antihemophilic Factor (Human) | 351(a) | 250IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 14, 2001 | 1062 | Supplement | 1898 | 001 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 101448 | Hemofil M | Antihemophilic Factor (Human) | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 14, 2001 | 1062 | Supplement | 1898 | 002 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 101448 | Hemofil M | Antihemophilic Factor (Human) | 351(a) | 1700IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 14, 2001 | 1062 | Supplement | 1898 | 003 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 101448 | Hemofil M | Antihemophilic Factor (Human) | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 14, 2001 | 1062 | Supplement | 1898 | 004 | CBER | ||||||||||
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Kamada Ltd. | 125035 | Hepagam B | Hepatitis B Immune Globulin (Human) | 351(a) | >1560IU/5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | January 27, 2006 | 0 | Original | 1826 | 001 | CBER | April 6, 2014 | |||||||||
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Kamada Ltd. | 125035 | Hepagam B | Hepatitis B Immune Globulin (Human) | 351(a) | >312IU/ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | January 27, 2006 | 0 | Original | 1826 | 002 | CBER | April 6, 2014 | |||||||||
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Dynavax Technologies Corporation | 125428 | Heplisav-B | Hepatitis B Vaccine (Recombinant), Adjuvanted | 351(a) | 20UG/.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | November 9, 2017 | 0 | Original | 1883 | 001 | CBER | ||||||||||
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Genentech, Inc. | 103792 | Herceptin | trastuzumab | 351(a) | 420MG | For Injection | Intravenous | Multi-Dose Vial | Disc* | Licensed | September 25, 1998 | Original | 1048 | 001 | CDER | October 20, 2017 | Yes | |||||||||
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Genentech, Inc. | 103792 | Herceptin | trastuzumab | 351(a) | 150MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 10, 2017 | 5336 | Supplement | 1048 | 002 | CDER | October 20, 2017 | Yes | ||||||||
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Genentech, Inc. | 761106 | Herceptin Hylecta | trastuzumab and hyaluronidase-oysk | 351(a) | 600MG/5ML;10,000 UNITS/5ML (120MG/2,000UNITS/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | February 28, 2019 | Original | 1048 | 001 | CDER | |||||||||||
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Accord BioPharma Inc. | 761346 | Hercessi | trastuzumab-strf | 351(k) Biosimilar | 150MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 25, 2024 | trastuzumab | Herceptin | Original | 2105 | 001 | CDER | |||||||||
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Accord BioPharma Inc. | 761346 | Hercessi | trastuzumab-strf | 351(k) Biosimilar | 420MG | For Injection | Intravenous | Multi-Dose Vial | Rx | Licensed | September 6, 2024 | trastuzumab | Herceptin | 1 | Supplement | 2105 | 002 | CDER | ||||||||
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CELLTRION, Inc. | 761091 | Herzuma | trastuzumab-pkrb | 351(k) Biosimilar | 420MG | For Injection | Intravenous | Multi-Dose Vial | Rx | Licensed | December 14, 2018 | trastuzumab | Herceptin | Original | 1996 | 001 | CDER | |||||||||
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CELLTRION, Inc. | 761091 | Herzuma | trastuzumab-pkrb | 351(k) Biosimilar | 150MG | For injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 16, 2019 | trastuzumab | Herceptin | 1 | Supplement | 1996 | 002 | CDER | ||||||||
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GlaxoSmithKline Biologicals | 125347 | Hiberix | Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) | 351(a) | 10UG/25UG | For Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | August 19, 2009 | 0 | Original | 1617 | 001 | CBER | ||||||||||
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ALK-Abello, Inc. | 103754 | Histatrol | Positive Skin Test Control-Histamine | 351(a) | 0.1MG/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 001 | CBER | ||||||||||
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ALK-Abello, Inc. | 103754 | Histatrol | Positive Skin Test Control-Histamine | 351(a) | 1MG/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 002 | CBER | ||||||||||
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CSL Behring AG | 125350 | Hizentra | Immune Globulin Subcutaneous (Human), 20% Liquid | 351(a) | 2G/10ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | March 4, 2010 | 0 | Original | 1766 | 001 | CBER | March 15, 2025 | |||||||||
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CSL Behring AG | 125350 | Hizentra | Immune Globulin Subcutaneous (Human), 20% Liquid | 351(a) | 1G/5ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | March 4, 2010 | 0 | Original | 1766 | 002 | CBER | March 15, 2025 | |||||||||
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CSL Behring AG | 125350 | Hizentra | Immune Globulin Subcutaneous (Human), 20% Liquid | 351(a) | 10G/50ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | March 4, 2010 | 0 | Original | 1766 | 003 | CBER | March 15, 2025 | |||||||||
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CSL Behring AG | 125350 | Hizentra | Immune Globulin Subcutaneous (Human), 20% Liquid | 351(a) | 4G/20ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | March 4, 2010 | 0 | Original | 1766 | 004 | CBER | March 15, 2025 | |||||||||
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CSL Behring AG | 125350 | Hizentra | Immune Globulin Subcutaneous (Human), 20% Liquid | 351(a) | 10G/50ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | April 13, 2023 | 1217 | Supplement | 1766 | 005 | CBER | March 15, 2025 | |||||||||
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SmartPractice Denmark ApS | 125579 | hudquzco rubber panel,rubber panel t.r.u.e. test | Rubber Panel Thin-Layer Rapid Use Epicutaneous Patch Test | 351(a) | PATCH TEST 5 ALLERGEN AND ALLERGEN MIX PATCHES AND A NEGATIVE CONTROL. | Patch | Topical | Blister Pack | Rx | Licensed | March 3, 2017 | 0 | Original | 1888 | 001 | CBER | ||||||||||
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Biocon Biologics Inc. | 761154 | Hulio | adalimumab-fkjp | 351(k) Interchangeable | 40MG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | July 6, 2020 | February 5, 2025 | adalimumab | Humira | Original | 9 | 2324 | 002 | CDER | |||||||
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Biocon Biologics Inc. | 761154 | Hulio | adalimumab-fkjp | 351(k) Interchangeable | 20MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | July 6, 2020 | February 5, 2025 | adalimumab | Humira | Original | 9 | 2324 | 003 | CDER | |||||||
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Biocon Biologics Inc. | 761154 | Hulio | adalimumab-fkjp | 351(k) Interchangeable | 40MG/0.8ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | July 6, 2020 | February 5, 2025 | adalimumab | Humira | Original | 9 | 2324 | 001 | CDER | |||||||
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Eli Lilly and Company | 020563 | Humalog | insulin lispro | 351(a) | 1,000UNITS/10ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 14, 1996 | Original | 1891 | 001 | CDER | |||||||||||
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Eli Lilly and Company | 020563 | Humalog | insulin lispro | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 14, 1996 | Original | 1891 | 006 | CDER | |||||||||||
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Eli Lilly and Company | 020563 | Humalog | insulin lispro | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Multi-Dose Cartridge | Disc | Licensed | August 6, 1998 | 6 | Supplement | 1891 | 002 | CDER | ||||||||||
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Eli Lilly and Company | 020563 | Humalog | insulin lispro | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | September 6, 2007 | 75 | Supplement | 1891 | 003 | CDER | ||||||||||
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Eli Lilly and Company | 205747 | Humalog | insulin lispro | 351(a) | 600UNITS/3ML (200UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | May 26, 2015 | Original | 1891 | 001 | CDER | |||||||||||
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Eli Lilly and Company | 205747 | Humalog | insulin lispro | 351(a) | 600UNITS/3ML (200UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | May 7, 2025 | 38 | Supplement | 1891 | 002 | CDER | ||||||||||
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Eli Lilly and Company | 020563 | Humalog | insulin lispro | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | June 6, 2017 | 176 | Supplement | 1891 | 004 | CDER | ||||||||||
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Eli Lilly and Company | 020563 | Humalog | insulin lispro | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | November 15, 2019 | 196 | Supplement | 1891 | 005 | CDER | ||||||||||
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Eli Lilly and Company | 021018 | Humalog Mix 50/50 | insulin lispro protamine and insulin lispro | 351(a) | 500UNITS/10ML (50UNITS/ML); 500UNITS/10ML (50UNITS/ML) | Injectable Suspension | Subcutaneous | Multi-Dose Vial | Disc | Licensed | December 22, 1999 | Original | 1891 | 001 | CDER | |||||||||||
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Eli Lilly and Company | 021018 | Humalog Mix 50/50 | insulin lispro protamine and insulin lispro | 351(a) | 150UNITS/3ML (50UNITS/ML); 150UNITS/3ML (50UNITS/ML) | Injectable Suspension | Subcutaneous | Autoinjector | Disc | Licensed | December 22, 1999 | Original | 1891 | 003 | CDER | |||||||||||
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Eli Lilly and Company | 021018 | Humalog Mix 50/50 | insulin lispro protamine and insulin lispro | 351(a) | 150UNITS/3ML (50UNITS/ML); 150UNITS/3ML (50UNITS/ML) | Injectable Suspension | Subcutaneous | Autoinjector | Rx | Licensed | September 6, 2007 | 34 | Supplement | 1891 | 002 | CDER | ||||||||||
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Eli Lilly and Company | 021017 | Humalog Mix 75/25 | insulin lispro protamine and insulin lispro | 351(a) | 750UNITS/10ML (75UNITS/ML); 250UNITS/10ML (25UNITS/ML) | Injectable Suspension | Subcutaneous | Multi-Dose Vial | Rx | Licensed | December 22, 1999 | Original | 1891 | 001 | CDER | |||||||||||
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Eli Lilly and Company | 021017 | Humalog Mix 75/25 | insulin lispro protamine and insulin lispro | 351(a) | 225UNITS/3ML (75UNITS/ML); 75UNITS/3ML (25UNITS/ML) | Injectable Suspension | Subcutaneous | Autoinjector | Disc | Licensed | December 22, 1999 | Original | 1891 | 003 | CDER | |||||||||||
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Eli Lilly and Company | 021017 | Humalog Mix 75/25 | insulin lispro protamine and insulin lispro | 351(a) | 225UNITS/3ML (75UNITS/ML); 75UNITS/3ML (25UNITS/ML) | Injectable Suspension | Subcutaneous | Autoinjector | Rx | Licensed | September 6, 2007 | 40 | Supplement | 1891 | 002 | CDER | ||||||||||
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Instituto Grifols, S.A. | 103352 | Human Albumin Grifols | Albumin (Human) | 351(a) | 12.5G/50ML | Injection | Intravenous | Single-Dose Vial | Disc | Licensed | February 17, 1995 | 5024 | Supplement | 1181 | 001 | CBER | ||||||||||
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Instituto Grifols, S.A. | 103352 | Human Albumin Grifols | Albumin (Human) | 351(a) | 20G/100ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 11, 2003 | 0 | Original | 1181 | 002 | CBER | ||||||||||
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Instituto Grifols, S.A. | 103352 | Human Albumin Grifols | Albumin (Human) | 351(a) | 10G/50ML | Injection | Intravenous | Single-Dose Vial | Disc | Licensed | February 17, 1995 | 5024 | Supplement | 1181 | 003 | CBER | ||||||||||
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Instituto Grifols, S.A. | 103352 | Human Albumin Grifols | Albumin (Human) | 351(a) | 25G/100ML | Injection | Intravenous | Single-Dose Vial | Disc | Licensed | June 11, 2003 | 0 | Original | 1181 | 004 | CBER | ||||||||||
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CSL Behring GmbH | 103960 | Humate-P | Antihemophilic Factor/von Willebrand Factor Complex (Human) | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 11, 2000 | 0 | Original | 1765 | 001 | CBER | April 1, 2006 | |||||||||
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CSL Behring GmbH | 103960 | Humate-P | Antihemophilic Factor/von Willebrand Factor Complex (Human) | 351(a) | 250IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 11, 2000 | 0 | Original | 1765 | 002 | CBER | April 1, 2006 | |||||||||
|
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CSL Behring GmbH | 103960 | Humate-P | Antihemophilic Factor/von Willebrand Factor Complex (Human) | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 11, 2000 | 0 | Original | 1765 | 003 | CBER | April 1, 2006 | |||||||||
|
|
Eli Lilly and Company | 019640 | Humatrope | somatropin | 351(a) | 5MG | For Injection | Subcutaneous | Single-Dose Vial | Disc | Licensed | October 16, 1986 | Original | 1891 | 004 | CDER | November 1, 2013 | ||||||||||
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Eli Lilly and Company | 019640 | Humatrope | somatropin | 351(a) | 2MG | For Injection | Subcutaneous | Single-Dose Vial | Disc | Licensed | June 23, 1987 | 1 | Supplement | 1891 | 001 | CDER | November 1, 2013 | |||||||||
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Eli Lilly and Company | 019640 | Humatrope | somatropin | 351(a) | 6MG | For Injection | Subcutaneous | Multi-Dose Cartridge | Rx | Licensed | February 4, 1999 | 22 | Supplement | 1891 | 005 | CDER | November 1, 2013 | |||||||||
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Eli Lilly and Company | 019640 | Humatrope | somatropin | 351(a) | 12MG | For Injection | Subcutaneous | Multi-Dose Cartridge | Rx | Licensed | February 4, 1999 | 22 | Supplement | 1891 | 006 | CDER | November 1, 2013 | |||||||||
|
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Eli Lilly and Company | 019640 | Humatrope | somatropin | 351(a) | 24MG | For Injection | Subcutaneous | Multi-Dose Cartridge | Rx | Licensed | February 4, 1999 | 22 | Supplement | 1891 | 007 | CDER | November 1, 2013 | |||||||||
|
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Organon USA Inc., a subsidiary of Merck & Co., Inc. | 020328 | Humegon | menotropins | 351(a) | 75IU | For Injection | Intramuscular | Single-Dose Vial | Disc | Voluntarily Revoked | September 1, 1994 | Original | 2193 | 001 | CDER | |||||||||||
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Organon USA Inc., a subsidiary of Merck & Co., Inc. | 020328 | Humegon | menotropins | 351(a) | 150IU | For Injection | Intramuscular | Single-Dose Vial | Disc | Voluntarily Revoked | September 1, 1994 | Original | 2193 | 002 | CDER | |||||||||||
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|
AbbVie Inc. | 125057 | Humira | adalimumab | 351(a) | 40MG/0.8ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | December 31, 2002 | Original | 1889 | 001 | CDER | February 24, 2028 | Yes | |||||||||
|
|
AbbVie Inc. | 125057 | Humira | adalimumab | 351(a) | 40MG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | December 31, 2002 | Original | 1889 | 002 | CDER | February 24, 2028 | Yes | |||||||||
|
|
AbbVie Inc. | 125057 | Humira | adalimumab | 351(a) | 20MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc* | Licensed | February 21, 2008 | 114 | Supplement | 1889 | 003 | CDER | February 24, 2028 | Yes | ||||||||
|
|
AbbVie Inc. | 125057 | Humira | adalimumab | 351(a) | 40MG/0.8ML | Injection | Subcutaneous | Single-Dose Vial | Disc | Licensed | April 24, 2013 | 322 | Supplement | 1889 | 004 | CDER | February 24, 2028 | Yes | ||||||||
|
|
AbbVie Inc. | 125057 | Humira | adalimumab | 351(a) | 10MG/0.2ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc* | Licensed | September 23, 2014 | 356 | Supplement | 1889 | 005 | CDER | February 24, 2028 | Yes | ||||||||
|
|
AbbVie Inc. | 125057 | Humira | adalimumab | 351(a) | 40MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | November 23, 2015 | 394 | Supplement | 1889 | 006 | CDER | February 24, 2028 | Yes | ||||||||
|
|
AbbVie Inc. | 125057 | Humira | adalimumab | 351(a) | 40MG/0.4ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | March 9, 2016 | 398 | Supplement | 1889 | 007 | CDER | February 24, 2028 | Yes | ||||||||
|
|
AbbVie Inc. | 125057 | Humira | adalimumab | 351(a) | 80MG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | October 17, 2016 | 400 | Supplement | 1889 | 008 | CDER | February 24, 2028 | Yes | ||||||||
|
|
AbbVie Inc. | 125057 | Humira | adalimumab | 351(a) | 80MG/0.8ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | April 21, 2017 | 401 | Supplement | 1889 | 009 | CDER | February 24, 2028 | Yes | ||||||||
|
|
AbbVie Inc. | 125057 | Humira | adalimumab | 351(a) | 20MG/0.2ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | April 28, 2017 | 402 | Supplement | 1889 | 010 | CDER | February 24, 2028 | Yes | ||||||||
|
|
AbbVie Inc. | 125057 | Humira | adalimumab | 351(a) | 10MG/0.1ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | April 28, 2017 | 402 | Supplement | 1889 | 011 | CDER | February 24, 2028 | Yes | ||||||||
|
|
Eli Lilly and Company | 019717 | Humulin 70/30 | insulin isophane human and insulin human | 351(a) | 700UNITS/10ML (70UNITS/ML); 300UNITS/10ML (30UNITS/ML) | Injectable Suspension | Subcutaneous | Multi-Dose Vial | OTC | Licensed | April 25, 1989 | Original | 1891 | 001 | CDER | |||||||||||
|
|
Eli Lilly and Company | 019717 | Humulin 70/30 | insulin isophane human and insulin human | 351(a) | 210UNITS/3ML (70UNITS/ML); 90UNITS/3ML (30UNITS/ML) | Injectable Suspension | Subcutaneous | Multi-Dose Vial | OTC | Licensed | April 25, 1989 | Original | 1891 | 002 | CDER | |||||||||||
|
|
Eli Lilly and Company | 019717 | Humulin 70/30 | insulin isophane human and insulin human | 351(a) | 210UNITS/3ML (70UNITS/ML); 90UNITS/3ML (30UNITS/ML) | Injectable Suspension | Subcutaneous | Autoinjector | OTC | Licensed | November 7, 2013 | 98 | Supplement | 1891 | 003 | CDER | ||||||||||
|
|
Eli Lilly and Company | 018781 | Humulin N | insulin isophane human | 351(a) | 1,000UNITS/10ML (100UNITS/ML) | Injectable Suspension | Subcutaneous | Multi-Dose Vial | OTC | Licensed | October 28, 1982 | Original | 1891 | 001 | CDER | |||||||||||
|
|
Eli Lilly and Company | 018781 | Humulin N | insulin isophane human | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injectable Suspension | Subcutaneous | Multi-Dose Vial | OTC | Licensed | October 28, 1982 | Original | 1891 | 002 | CDER | |||||||||||
|
|
Eli Lilly and Company | 018781 | Humulin N | insulin isophane human | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injectable Suspension | Subcutaneous | Autoinjector | OTC | Licensed | November 7, 2013 | 118 | Supplement | 1891 | 003 | CDER | ||||||||||
|
|
Eli Lilly and Company | 018780 | Humulin R U-100 | insulin human | 351(a) | 1,000UNITS/10ML (100UNITS/ML) | Injection | Subcutaneous | Multi-Dose Vial | OTC | Licensed | October 28, 1982 | Original | 1891 | 001 | CDER | |||||||||||
|
|
Eli Lilly and Company | 018780 | Humulin R U-100 | insulin human | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Disc | Licensed | August 6, 1998 | 58 | Supplement | 1891 | 003 | CDER | ||||||||||
|
|
Eli Lilly and Company | 018780 | Humulin R U-100 | insulin human | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Multi-Dose Vial | OTC | Licensed | May 25, 2018 | 126 | Supplement | 1891 | 005 | CDER | ||||||||||
|
|
Eli Lilly and Company | 018780 | Humulin R U-500 | insulin human | 351(a) | 10,000UNITS/20ML (500UNITS/ML) | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 31, 1994 | 42 | Supplement | 1891 | 004 | CDER | ||||||||||
|
|
Eli Lilly and Company | 018780 | Humulin R U-500 | insulin human | 351(a) | 1,500UNITS/3ML (500UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | December 29, 2015 | 152 | Supplement | 1891 | 002 | CDER | ||||||||||
|
|
Akorn, Inc. | 021716 | Hydase | hyaluronidase | 351(a) | 150UNITS/ML | Injection | Subcutaneous | Single-Dose Vial | Disc | Licensed | October 25, 2005 | Original | 2173 | 001 | CDER | |||||||||||
|
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Halozyme Therapeutics, Inc. | 021859 | Hylenex recombinant | hyaluronidase human | 351(a) | 150UNITS/ML | Injection | Infiltration, Interstitial, Intramuscular, Intraocular, Peribulbar, Retrobulbar, Soft Tissue, Subcutaneous | Single-Dose Vial | Rx | Licensed | December 2, 2005 | Original | 2187 | 001 | CDER | |||||||||||
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Pfizer Inc. | 761369 | Hympavzi | marstacimab-hncq | 351(a) | 150MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | October 11, 2024 | Original | 2001 | 001 | CDER | October 11, 2031 | ||||||||||
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Pfizer Inc. | 761369 | Hympavzi | marstacimab-hncq | 351(a) | 150MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | October 11, 2024 | Original | 2001 | 002 | CDER | October 11, 2031 | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 125402 | Hyqvia | Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase | 351(a) | 10% | Injection | Subcutaneous | Bottle | Rx | Licensed | September 12, 2014 | 0 | Original | 1898 | 001 | CBER | January 12, 2031 | |||||||||
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Sandoz Inc. | 761071 | Hyrimoz | adalimumab-adaz | 351(k) Interchangeable | 40MG/0.4ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | March 20, 2023 | July 29, 2025 | adalimumab | Humira | 14 | Supplement | 24 | 2003 | 004 | CDER | ||||||
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Sandoz Inc. | 761071 | Hyrimoz | adalimumab-adaz | 351(k) Interchangeable | 80MG/0.8ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | March 20, 2023 | July 29, 2025 | adalimumab | Humira | 14 | Supplement | 24 | 2003 | 005 | CDER | ||||||
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Sandoz Inc. | 761071 | Hyrimoz | adalimumab-adaz | 351(k) Interchangeable | 40MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | March 20, 2023 | May 20, 2025 | adalimumab | Humira | 14 | Supplement | 22 | 2003 | 007 | CDER | ||||||
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Sandoz Inc. | 761071 | Hyrimoz | adalimumab-adaz | 351(k) Interchangeable | 40MG/0.8ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | October 30, 2018 | July 29, 2025 | adalimumab | Humira | Original | 24 | 2003 | 002 | CDER | |||||||
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Sandoz Inc. | 761071 | Hyrimoz | adalimumab-adaz | 351(k) Interchangeable | 40MG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | October 30, 2018 | April 5, 2024 | adalimumab | Humira | Original | 19 | 2003 | 001 | CDER | |||||||
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Sandoz Inc. | 761071 | Hyrimoz | adalimumab-adaz | 351(k) Interchangeable | 80MG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | March 20, 2023 | April 5, 2024 | adalimumab | Humira | 14 | Supplement | 19 | 2003 | 008 | CDER | 45752 | |||||
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Sandoz Inc. | 761071 | Hyrimoz | adalimumab-adaz | 351(k) Interchangeable | 10MG/0.1ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | March 20, 2023 | April 5, 2024 | adalimumab | Humira | 14 | Supplement | 19 | 2003 | 009 | CDER | 45752 | |||||
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Sandoz Inc. | 761071 | Hyrimoz | adalimumab-adaz | 351(k) Interchangeable | 20MG/0.2ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | March 20, 2023 | April 5, 2024 | adalimumab | Humira | 14 | Supplement | 19 | 2003 | 010 | CDER | 45752 | |||||
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Sandoz Inc. | 761071 | Hyrimoz | adalimumab-adaz | 351(k) Interchangeable | 20MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | March 20, 2023 | April 5, 2024 | adalimumab | Humira | 14 | Supplement | 19 | 2003 | 006 | CDER | ||||||
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Sandoz Inc. | 761071 | Hyrimoz | adalimumab-adaz | 351(k) Interchangeable | 10MG/0.2ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | March 28, 2022 | April 5, 2024 | adalimumab | Humira | 11 | Supplement | 19 | 2003 | 003 | CDER | ||||||
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Fresenius Kabi USA, LLC | 761255 | Idacio | adalimumab-aacf | 351(k) Biosimilar | 40MG/0.8ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | December 13, 2022 | adalimumab | Humira | Original | 2146 | 001 | CDER | |||||||||
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Fresenius Kabi USA, LLC | 761255 | Idacio | adalimumab-aacf | 351(k) Biosimilar | 40MG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | December 13, 2022 | adalimumab | Humira | Original | 2146 | 002 | CDER | |||||||||
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Fresenius Kabi USA, LLC | 761255 | Idacio | adalimumab-aacf | 351(k) Biosimilar | 40MG/0.8ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | January 5, 2024 | adalimumab | Humira | Original | 2146 | 003 | CDER | |||||||||
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CSL Behring Lengnau AG | 125582 | Idelvion | Coagulation Factor IX (Recombinant), Albumin Fusion Protein | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 4, 2016 | 0 | Original | 2009 | 001 | CBER | March 4, 2023 | |||||||||
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CSL Behring Lengnau AG | 125582 | Idelvion | Coagulation Factor IX (Recombinant), Albumin Fusion Protein | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 4, 2016 | 0 | Original | 2009 | 002 | CBER | March 4, 2023 | |||||||||
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CSL Behring Lengnau AG | 125582 | Idelvion | Coagulation Factor IX (Recombinant), Albumin Fusion Protein | 351(a) | 2000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 4, 2016 | 0 | Original | 2009 | 003 | CBER | March 4, 2023 | |||||||||
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CSL Behring Lengnau AG | 125582 | Idelvion | Coagulation Factor IX (Recombinant), Albumin Fusion Protein | 351(a) | 250IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 4, 2016 | 0 | Original | 2009 | 004 | CBER | March 4, 2023 | |||||||||
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CSL Behring Lengnau AG | 125582 | Idelvion | Coagulation Factor IX (Recombinant), Albumin Fusion Protein | 351(a) | 3500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 30, 2018 | 116 | Supplement | 2009 | 005 | CBER | March 4, 2023 | |||||||||
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Novartis Pharmaceuticals Corporation | 125319 | Ilaris | canakinumab | 351(a) | 150MG | For Injection | Subcutaneous | Single-Dose Vial | Disc | Licensed | June 17, 2009 | Original | 1244 | 001 | CDER | June 16, 2027 | ||||||||||
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Novartis Pharmaceuticals Corporation | 125319 | Ilaris | canakinumab | 351(a) | 150MG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | December 22, 2016 | 88 | Supplement | 1244 | 002 | CDER | June 16, 2027 | |||||||||
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Sun Pharmaceutical Industries Limited | 761067 | Ilumya | tildrakizumab-asmn | 351(a) | 100MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | March 20, 2018 | Original | 2092 | 001 | CDER | |||||||||||
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Janssen Biotech, Inc. | 761430 | Imaavy | nipocalimab-aahu | 351(a) | 300MG/1.62ML (185MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 29, 2025 | Original | 1864 | 001 | CDER | |||||||||||
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Janssen Biotech, Inc. | 761430 | Imaavy | nipocalimab-aahu | 351(a) | 1,200MG/6.5ML (185MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 29, 2025 | Original | 1864 | 002 | CDER | |||||||||||
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Amgen Inc. | 761344 | Imdelltra | tarlatamab-dlle | 351(a) | 1MG | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 16, 2024 | Original | 1080 | 001 | CDER | May 16, 2031 | ||||||||||
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Amgen Inc. | 761344 | Imdelltra | tarlatamab-dlle | 351(a) | 10MG | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 16, 2024 | Original | 1080 | 002 | CDER | May 16, 2031 | ||||||||||
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AstraZeneca UK Ltd | 761069 | Imfinzi | durvalumab | 351(a) | 500MG/10ML (50MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 1, 2017 | Original | 2043 | 001 | CDER | December 4, 2031 | ||||||||||
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AstraZeneca UK Ltd | 761069 | Imfinzi | durvalumab | 351(a) | 120MG/2.4ML (50MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 1, 2017 | Original | 2043 | 002 | CDER | December 4, 2031 | ||||||||||
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AstraZeneca AB | 761289 | Imjudo | tremelimumab-actl | 351(a) | 25MG/1.25ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 21, 2022 | Original | 2059 | 001 | CDER | October 21, 2029 | ||||||||||
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AstraZeneca AB | 761289 | Imjudo | tremelimumab-actl | 351(a) | 300MG/15ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 21, 2022 | Original | 2059 | 002 | CDER | October 21, 2029 | ||||||||||
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Amgen Inc. | 125518 | Imlygic | Talimogene laherparepvec | 351(a) | 100 MILLION PFU/ML | For Injection | Intralesional | Single-Dose Vial | Rx | Licensed | October 27, 2015 | 0 | Original | 1080 | 001 | CBER | October 27, 2022 | |||||||||
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Amgen Inc. | 125518 | Imlygic | Talimogene laherparepvec | 351(a) | 1 MILLION PFU/ML | For Injection | Intralesional | Single-Dose Vial | Rx | Licensed | October 27, 2015 | 0 | Original | 1080 | 002 | CBER | October 27, 2022 | |||||||||
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Sanofi Winthrop Industrie | 103932 | Imogam | Rabies Immune Globulin (Human) | 351(a) | 150IU/ML | For Injection | Intramuscular | Single-Dose Vial | Disc | Voluntarily Revoked | March 6, 2001 | 5000 | Supplement | 1724 | 001 | CBER | ||||||||||
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Sanofi Winthrop Industrie | 103931 | Imovax Rabies | Rabies Vaccine | 351(a) | 2.5IU/ML | For Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | February 4, 2000 | 0 | Original | 1724 | 001 | CBER | ||||||||||
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Accord BioPharma Inc. | 761364 | Imuldosa | ustekinumab-srlf | 351(k) Biosimilar | 45MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | October 10, 2024 | ustekinumab | Stelara | Original | 2105 | 001 | CDER | |||||||||
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Accord BioPharma Inc. | 761364 | Imuldosa | ustekinumab-srlf | 351(k) Biosimilar | 90MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | October 10, 2024 | ustekinumab | Stelara | Original | 2105 | 002 | CDER | |||||||||
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Accord BioPharma Inc. | 761364 | Imuldosa | ustekinumab-srlf | 351(k) Biosimilar | 130MG/26ML (5MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 10, 2024 | ustekinumab | Stelara | Original | 2105 | 003 | CDER | |||||||||
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Eton Pharmaceuticals, Inc. | 021839 | Increlex | mecasermin | 351(a) | 40MG/4ML (10MG/ML) | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | August 30, 2005 | Original | 2393 | 001 | CDER | August 30, 2012 | ||||||||||
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GlaxoSmithKline Biologicals | 103647 | Infanrix | Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed | 351(a) | 25LF/10LF/25UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | January 29, 1997 | 0 | Original | 1617 | 001 | CBER | ||||||||||
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GlaxoSmithKline Biologicals | 103647 | Infanrix | Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed | 351(a) | 25LF/10LF/25UG/.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | January 29, 1997 | 0 | Original | 1617 | 002 | CBER | ||||||||||
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ONY Biotech Inc. | 020521 | Infasurf | calfactant | 351(a) | 210MG/6ML (35MG/ML) | Suspension | Intratracheal | Single-Dose Vial | Rx | Licensed | July 1, 1998 | Original | 2192 | 001 | CDER | |||||||||||
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ONY Biotech Inc. | 020521 | Infasurf | calfactant | 351(a) | 105MG/3ML (35MG/ML) | Suspension | Intratracheal | Single-Dose Vial | Rx | Licensed | December 12, 2002 | 8 | Supplement | 2192 | 002 | CDER | ||||||||||
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Kadmon Pharmaceuticals LLC | 103663 | Infergen | interferon alfacon-1 | 351(a) | 9MCG/0.3ML (30MCG/ML) | Injection | Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | October 6, 1997 | 1867 | 001 | CDER | ||||||||||||
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CELLTRION, Inc. | 125544 | Inflectra | infliximab-dyyb | 351(k) Biosimilar | 100MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 5, 2016 | infliximab | Remicade | Original | 1996 | 001 | CDER | |||||||||
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Regeneron Pharmaceuticals, Inc. | 761169 | Inmazeb | atoltivimab, maftivimab, and odesivimab-ebgn | 351(a) | 241.7MG, 241.7MG, 241.7MG/14.5ML (16.67MG, 16.67MG, 16.67MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 14, 2020 | Original | 1760 | 001 | CDER | October 14, 2027 | ||||||||||
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Regeneron Pharmaceuticals, Inc. | 761169 | Inmazeb | atoltivimab, maftivimab, and odesivimab-ebgn | 351(a) | 483.3MG, 483.3MG, 483.3MG/14.5ML (33.33MG, 33.33MG, 33.33MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | September 29, 2021 | 2 | Supplement | 1760 | 002 | CDER | October 14, 2027 | |||||||||
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Merck Sharp & Dohme LLC | 103132 | Intron A | interferon alfa-2b | 351(a) | 3MIU | For Injection | Intramuscular, Intravenous, Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | June 4, 1986 | Original | 0002 | 001 | CDER | November 21, 1995 | ||||||||||
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Merck Sharp & Dohme LLC | 103132 | Intron A | interferon alfa-2b | 351(a) | 5MIU | For Injection | Intramuscular, Intravenous, Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | June 4, 1986 | Original | 0002 | 002 | CDER | November 21, 1995 | ||||||||||
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Merck Sharp & Dohme LLC | 103132 | Intron A | interferon alfa-2b | 351(a) | 10MIU | For Injection | Subcutaneous, Intravenous, Intralesional, Intramuscular | Single-Dose Vial | Disc | Voluntarily Revoked | June 4, 1986 | Original | 0002 | 003 | CDER | November 21, 1995 | ||||||||||
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Merck Sharp & Dohme LLC | 103132 | Intron A | interferon alfa-2b | 351(a) | 25MIU | For Injection | Intramuscular, Intravenous, Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | June 4, 1986 | Original | 0002 | 004 | CDER | November 21, 1995 | ||||||||||
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Merck Sharp & Dohme LLC | 103132 | Intron A | interferon alfa-2b | 351(a) | 18MIU | For Injection | Intramuscular, Intravenous, Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | Supplement | 0002 | 005 | CDER | November 21, 1995 | |||||||||||
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Merck Sharp & Dohme LLC | 103132 | Intron A | interferon alfa-2b | 351(a) | 50MIU | For Injection | Intramuscular, Intravenous, Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | Supplement | 0002 | 006 | CDER | November 21, 1995 | |||||||||||
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Merck Sharp & Dohme LLC | 103132 | Intron A | interferon alfa-2b | 351(a) | 3MIU | Injection | Subcutaneous, Intramuscular | Single-Dose Vial | Disc | Voluntarily Revoked | Supplement | 0002 | 007 | CDER | November 21, 1995 | |||||||||||
|
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Merck Sharp & Dohme LLC | 103132 | Intron A | interferon alfa-2b | 351(a) | 5MIU | Injection | Intralesional, Intramuscular, Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | Supplement | 0002 | 008 | CDER | November 21, 1995 | |||||||||||
|
|
Merck Sharp & Dohme LLC | 103132 | Intron A | interferon alfa-2b | 351(a) | 10MIU | Injection | Intralesional, Intramuscular, Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | Supplement | 0002 | 009 | CDER | November 21, 1995 | |||||||||||
|
|
Merck Sharp & Dohme LLC | 103132 | Intron A | interferon alfa-2b | 351(a) | 18MIU | Injection | Subcutaneous, Intramuscular | Multi-Dose Vial | Disc | Voluntarily Revoked | Supplement | 0002 | 010 | CDER | November 21, 1995 | |||||||||||
|
|
Merck Sharp & Dohme LLC | 103132 | Intron A | interferon alfa-2b | 351(a) | 25MIU | Injection | Intralesional, Intramuscular, Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | Supplement | 0002 | 011 | CDER | November 21, 1995 | |||||||||||
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Merck Sharp & Dohme LLC | 103132 | Intron A | interferon alfa-2b | 351(a) | 3MIU | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Voluntarily Revoked | Supplement | 0002 | 012 | CDER | November 21, 1995 | |||||||||||
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Merck Sharp & Dohme LLC | 103132 | Intron A | interferon alfa-2b | 351(a) | 5MIU | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Voluntarily Revoked | Supplement | 0002 | 013 | CDER | November 21, 1995 | |||||||||||
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Merck Sharp & Dohme LLC | 103132 | Intron A | interferon alfa-2b | 351(a) | 10MIU | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Voluntarily Revoked | Supplement | 0002 | 014 | CDER | November 21, 1995 | |||||||||||
|
|
Insmed Incorporated | 021884 | Iplex | mecasermin rinfabate | 351(a) | 36MG/0.6ML (60MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | December 12, 2005 | Original | 2188 | 001 | CDER | December 12, 2012 | ||||||||||
|
|
Sanofi Winthrop Industrie | 103930 | Ipol | Poliovirus Vaccine Inactivated | 351(a) | 32/40/8 DAU/.5ML | Injection | Intramuscular | Multi-Dose Vial | Rx | Licensed | February 4, 2000 | 0 | Original | 1724 | 001 | CBER | ||||||||||
|
|
Sanofi Winthrop Industrie | 103930 | Ipol | Poliovirus Vaccine Inactivated | 351(a) | 32/40/8 DAU/.5ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | February 4, 2000 | 0 | Original | 1724 | 002 | CBER | ||||||||||
|
|
Bausch Health US, LLC | 021271 | Iprivask | desirudin | 351(a) | 15MG | For Injection | Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | April 4, 2003 | Original | 2181 | 001 | CDER | |||||||||||
|
|
Novartis Gene Therapies, Inc. | 125856 | ITVISMA | onasemnogene abeparvovec-brve | 351(a) | 4x10^13VG/ML | Injection | Intrathecal | Single-Dose Vial | Rx | Licensed | November 24, 2025 | 0 | Original | 2250 | 001 | CBER | ||||||||||
|
|
Valneva Austria GmbH | 125777 | IXCHIQ | Chikungunya Vaccine, Live | 351(a) | 3.0 log10 TCID | For Injection | Intramuscular | Single-Dose Vial | Disc | Revoked | November 9, 2023 | 0 | Original | 1909 | 001 | CBER | ||||||||||
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Valneva Austria GmbH | 125280 | Ixiaro | Japanese Encephalitis Vaccine, Inactivated, Adsorbed | 351(a) | 0.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | March 30, 2009 | 0 | Original | 1909 | 001 | CBER | May 17, 2020 | |||||||||
|
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Pfizer Ireland Pharmaceuticals | 761072 | Ixifi | infliximab-qbtx | 351(k) Biosimilar | 100MG | For Injection | Intravenous | Single-Dose Vial | Disc | Licensed | December 13, 2017 | infliximab | Remicade | Original | 2060 | 001 | CDER | |||||||||
|
|
Medexus Pharma, Inc. | 125426 | Ixinity | Coagulation Factor IX (Recombinant) | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 29, 2015 | 0 | Original | 2220 | 001 | CBER | ||||||||||
|
|
Medexus Pharma, Inc. | 125426 | Ixinity | Coagulation Factor IX (Recombinant) | 351(a) | 1500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 29, 2015 | 0 | Original | 2220 | 002 | CBER | ||||||||||
|
|
Medexus Pharma, Inc. | 125426 | Ixinity | Coagulation Factor IX (Recombinant) | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 29, 2015 | 0 | Original | 2220 | 003 | CBER | ||||||||||
|
|
Medexus Pharma, Inc. | 125426 | Ixinity | Coagulation Factor IX (Recombinant) | 351(a) | 250IU | For Injection | Intravenous | Single-Dose Vial | Disc | Licensed | December 21, 2015 | 19 | Supplement | 2220 | 004 | CBER | ||||||||||
|
|
Medexus Pharma, Inc. | 125426 | Ixinity | Coagulation Factor IX (Recombinant) | 351(a) | 3000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 21, 2015 | 19 | Supplement | 2220 | 005 | CBER | ||||||||||
|
|
Medexus Pharma, Inc. | 125426 | Ixinity | Coagulation Factor IX (Recombinant) | 351(a) | 2000IU | For Injection | Intravenous | Single-Dose Vial | Disc | Licensed | December 21, 2015 | 19 | Supplement | 2220 | 006 | CBER | ||||||||||
|
|
Iso-Tex Diagnostics, Inc. | 017836 | Jeanatope | iodinated I-125 albumin | 351(a) | 500uCi/0.5ML (1,000uCi/ML) | Injection | Intravenous | Multi-Dose Vial | Disc | Voluntarily Revoked | February 23, 1976 | Original | 2189 | 001 | CDER | |||||||||||
|
|
Iso-Tex Diagnostics, Inc. | 017836 | Jeanatope | iodinated I-125 albumin | 351(a) | 1,000uCi/ML (1,000uCi/ML) | Injection | Intravenous | Multi-Dose Vial | Disc | Voluntarily Revoked | February 23, 1976 | Original | 2189 | 002 | CDER | |||||||||||
|
|
Iso-Tex Diagnostics, Inc. | 017836 | Jeanatope | iodinated I-125 albumin | 351(a) | 100uCi/10ML (10uCi/ML) | Injection | Intravenous | Multi-Dose Vial | Disc | Voluntarily Revoked | June 8, 2004 | 8 | Supplement | 2189 | 003 | CDER | ||||||||||
|
|
GlaxoSmithKline LLC | 761174 | Jemperli | dostarlimab-gxly | 351(a) | 500MG/10ML (50MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 22, 2021 | Original | 1727 | 001 | CDER | |||||||||||
|
|
ThromboGenics Inc. | 125422 | Jetrea | ocriplasmin | 351(a) | 0.5MG/0.2ML (2.5MG/ML) | Injection | Intravitreal | Single-Dose Vial | Disc | Voluntarily Revoked | October 17, 2012 | Original | 1866 | 002 | CDER | |||||||||||
|
|
ThromboGenics Inc. | 125422 | Jetrea | ocriplasmin | 351(a) | 0.375MG/0.3ML (1.25MG/ML) | Injection | Intravitreal | Single-Dose Vial | Disc | Voluntarily Revoked | February 22, 2017 | 38 | Supplement | 1866 | 001 | CDER | ||||||||||
|
|
Evolus Inc. | 761085 | Jeuveau | prabotulinumtoxinA-xvfs | 351(a) | 100UNITS | For Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | February 1, 2019 | Original | 2070 | 001 | CDER | |||||||||||
|
|
Bayer HealthCare LLC | 125661 | Jivi | Antihemophilic factor (recombinant), PEGylated-aucl | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 29, 2018 | 0 | Original | 0008 | 001 | CBER | ||||||||||
|
|
Bayer HealthCare LLC | 125661 | Jivi | Antihemophilic factor (recombinant), PEGylated-aucl | 351(a) | 3000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 29, 2018 | 0 | Original | 0008 | 002 | CBER | ||||||||||
|
|
Bayer HealthCare LLC | 125661 | Jivi | Antihemophilic factor (recombinant), PEGylated-aucl | 351(a) | 2000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 29, 2018 | 0 | Original | 0008 | 003 | CBER | ||||||||||
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Bayer HealthCare LLC | 125661 | Jivi | Antihemophilic factor (recombinant), PEGylated-aucl | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 29, 2018 | 0 | Original | 0008 | 004 | CBER | ||||||||||
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Bayer HealthCare LLC | 125661 | Jivi | Antihemophilic factor (recombinant), PEGylated-aucl | 351(a) | 4000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 2, 2024 | 982 | Supplement | 0008 | 005 | CBER | ||||||||||
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|
Biocon Biologics Inc. | 761175 | Jobevne | bevacizumab-nwgd | 351(k) Biosimilar | 100MG/4ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 9, 2025 | bevacizumab | Avastin | Original | 2324 | 001 | CDER | |||||||||
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Biocon Biologics Inc. | 761175 | Jobevne | bevacizumab-nwgd | 351(k) Biosimilar | 400MG/16ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 9, 2025 | bevacizumab | Avastin | Original | 2324 | 002 | CDER | |||||||||
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Sandoz Inc. | 761362 | Jubbonti | denosumab-bbdz | 351(k) Interchangeable | 60MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | March 5, 2024 | March 5, 2024 | denosumab | Prolia | Original | 2003 | 001 | CDER | 45959 | |||||||
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Accord BioPharma Inc. | 761424 | Jubereq | denosumab-desu | 351(k) Interchangeable | 120MG/1.7ML (70MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | October 29, 2025 | October 29, 2025 | denosumab | Xgeva | Original | 2105 | 002 | CDER | ||||||||
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Bavarian Nordic A/S | 125678 | Jynneos | Smallpox and Mpox Vaccine, Live, Non-replicating | 351(a) | 0.5-3.95 X 10E8 INF. U/.5ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | September 24, 2019 | 0 | Original | 2096 | 001 | CBER | ||||||||||
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Bavarian Nordic A/S | 125678 | Jynneos | Smallpox and Mpox Vaccine, Live, Non-replicating | 351(a) | 0.5-3.95 X 10E8 INF. U/.5ML | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | March 21, 2025 | 119 | Supplement | 2096 | 002 | CBER | ||||||||||
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Genentech, Inc. | 125427 | Kadcyla | ado-trastuzumab emtansine | 351(a) | 100MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 22, 2013 | Original | 1048 | 001 | CDER | |||||||||||
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Genentech, Inc. | 125427 | Kadcyla | ado-trastuzumab emtansine | 351(a) | 160MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 22, 2013 | Original | 1048 | 002 | CDER | |||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 125277 | Kalbitor | ecallantide | 351(a) | 10MG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | December 1, 2009 | Original | 1898 | 001 | CDER | March 28, 2021 | ||||||||||
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Amgen Inc. | 761073 | Kanjinti | trastuzumab-anns | 351(k) Biosimilar | 420MG | For Injection | Intravenous | Multi-Dose Vial | Rx | Licensed | June 13, 2019 | trastuzumab | Herceptin | Original | 1080 | 001 | CDER | |||||||||
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Amgen Inc. | 761073 | Kanjinti | trastuzumab-anns | 351(k) Biosimilar | 150MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 25, 2019 | trastuzumab | Herceptin | 1 | Supplement | 1080 | 002 | CDER | ||||||||
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Alexion Pharmaceuticals, Inc. | 125561 | Kanuma | sebelipase alfa | 351(a) | 20MG/10ML (2MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 8, 2015 | Original | 1743 | 001 | CDER | December 8, 2022 | ||||||||||
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|
CSL Behring GmbH | 125421 | Kcentra | Prothrombin Complex Concentrate (Human) | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 29, 2013 | 0 | Original | 1765 | 001 | CBER | December 13, 2020 | |||||||||
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CSL Behring GmbH | 125421 | Kcentra | Prothrombin Complex Concentrate (Human) | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 26, 2013 | 26 | Supplement | 1765 | 002 | CBER | December 13, 2020 | |||||||||
|
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PTC Therapeutics | 125722 | KEBILIDI | eladocagene exuparvovec-tneq | 351(a) | 5.6x10^11VG/ML | Suspension | Intraputaminal | Single-Dose Vial | Rx | Licensed | November 13, 2024 | 0 | Original | 2168 | 001 | CBER | November 13, 2031 | |||||||||
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Kedrion Biopharma Inc. | 125384 | Kedbumin | Albumin (Human) | 351(a) | 12.5G/50ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 3, 2011 | 0 | Original | 1906 | 001 | CBER | ||||||||||
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Kedrion Biopharma Inc. | 125384 | Kedbumin | Albumin (Human) | 351(a) | 25G/100ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | September 5, 2013 | 35 | Supplement | 1906 | 002 | CBER | ||||||||||
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|
Kamada Ltd. | 125613 | Kedrab | Rabies Immune Globulin (Human) | 351(a) | 150IU/ML | Solution | Subcutaneous | Single-Dose Vial | Rx | Licensed | August 23, 2017 | 0 | Original | 1826 | 001 | CBER | ||||||||||
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Swedish Orphan Biovitrum AB (publ) | 125103 | Kepivance | palifermin | 351(a) | 6.25MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 15, 2004 | Original | 1859 | 001 | CDER | |||||||||||
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Novartis Pharmaceuticals Corporation | 125326 | Kesimpta | ofatumumab | 351(a) | 20MG/0.4ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | August 20, 2020 | 70 | Supplement | 1244 | 003 | CDER | ||||||||||
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Novartis Pharmaceuticals Corporation | 125326 | Kesimpta | ofatumumab | 351(a) | 20MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | August 20, 2020 | 70 | Supplement | 1244 | 004 | CDER | ||||||||||
|
|
Sanofi-Aventis U.S. LLC | 761037 | Kevzara | sarilumab | 351(a) | 150MG/1.14ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | May 22, 2017 | Original | 1752 | 001 | CDER | |||||||||||
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Sanofi-Aventis U.S. LLC | 761037 | Kevzara | sarilumab | 351(a) | 200MG/1.14ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | May 22, 2017 | Original | 1752 | 002 | CDER | |||||||||||
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Sanofi-Aventis U.S. LLC | 761037 | Kevzara | sarilumab | 351(a) | 150MG/1.14ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | April 13, 2018 | 1 | Supplement | 1752 | 003 | CDER | ||||||||||
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Sanofi-Aventis U.S. LLC | 761037 | Kevzara | sarilumab | 351(a) | 200MG/1.14ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | April 13, 2018 | 1 | Supplement | 1752 | 004 | CDER | ||||||||||
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Merck Sharp & Dohme LLC | 125514 | Keytruda | pembrolizumab | 351(a) | 50MG | For Injection | Intravenous | Single-Dose Vial | Disc | Licensed | September 4, 2014 | Original | 0002 | 001 | CDER | January 25, 2031 | ||||||||||
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Merck Sharp & Dohme LLC | 125514 | Keytruda | pembrolizumab | 351(a) | 100MG/4ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | January 15, 2015 | 1 | Supplement | 0002 | 002 | CDER | January 25, 2031 | |||||||||
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Merck Sharp & Dohme LLC | 761467 | Keytruda Qlex | pembrolizumab and berahyaluronidase alfa-pmph | 351(a) | 395MG/2.4ML; 4,800UNITS/2.4ML (165MG/2,000UNITS/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | September 19, 2025 | Original | 0002 | 001 | CDER | |||||||||||
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Merck Sharp & Dohme LLC | 761467 | Keytruda Qlex | pembrolizumab and berahyaluronidase alfa-pmph | 351(a) | 790MG/4.8ML; 9,600UNITS/4.8ML (165MG/2,000UNITS/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | September 19, 2025 | Original | 0002 | 002 | CDER | |||||||||||
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Immunocore Limited | 761228 | Kimmtrak | tebentafusp-tebn | 351(a) | 100MCG/0.5ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | January 25, 2022 | Original | 2239 | 001 | CDER | January 25, 2029 | ||||||||||
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Swedish Orphan Biovitrum AB (publ) | 103950 | Kineret | anakinra | 351(a) | 100MG/0.67ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | November 14, 2001 | Original | 1859 | 001 | CDER | December 18, 2027 | ||||||||||
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Microbix Biosystems Inc. | 021846 | Kinlytic | urokinase | 351(a) | 250,000IU | For Injection | Intravenous | Single-Dose Vial | Disc | Licensed | January 16, 1978 | Original | 2191 | 001 | CDER | |||||||||||
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Microbix Biosystems Inc. | 021846 | Kinlytic | urokinase | 351(a) | 9,000IU | For Injection | Intravenous | Single-Dose Vial | Disc | Licensed | January 16, 1978 | Original | 2191 | 002 | CDER | |||||||||||
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Microbix Biosystems Inc. | 021846 | Kinlytic | urokinase | 351(a) | 5,000IU | For Injection | Intravenous | Single-Dose Vial | Disc | Licensed | January 16, 1978 | Original | 2191 | 003 | CDER | |||||||||||
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GlaxoSmithKline Biologicals | 125260 | Kinrix | Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine | 351(a) | 0.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | June 24, 2008 | 0 | Original | 1617 | 001 | CBER | ||||||||||
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Biocon Biologics Inc. | 761188 | Kirsty | insulin aspart-xjhz | 351(k) Interchangeable | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | July 15, 2025 | July 15, 2025 | insulin aspart | Novolog | Original | 2324 | 001 | CDER | Date TBD | |||||||
|
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Biocon Biologics Inc. | 761188 | Kirsty | insulin aspart-xjhz | 351(k) Interchangeable | 1,000UNITS/10ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Multi-Dose Vial | Rx | Licensed | July 15, 2025 | July 15, 2025 | insulin aspart | Novolog | Original | 2324 | 002 | CDER | Date TBD | |||||||
|
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Eli Lilly and Company | 761248 | Kisunla | donanemab-azbt | 351(a) | 350MG/20ML (17.5MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 2, 2024 | Original | 1891 | 001 | CDER | |||||||||||
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Grifols Therapeutics LLC | 101130 | Koate, Koate-Dvi | Antihemophilic Factor (Human) | 351(a) | 1,000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | January 24, 1974 | 0 | Original | 1871 | 001 | CBER | ||||||||||
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Grifols Therapeutics LLC | 101130 | Koate, Koate-Dvi | Antihemophilic Factor (Human) | 351(a) | 250IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | January 24, 1974 | 0 | Original | 1871 | 002 | CBER | ||||||||||
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Grifols Therapeutics LLC | 101130 | Koate, Koate-Dvi | Antihemophilic Factor (Human) | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | January 24, 1974 | 0 | Original | 1871 | 003 | CBER | ||||||||||
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Bayer HealthCare LLC | 125574 | Kovaltry | Antihemophilic Factor (Recombinant), Full Length | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 16, 2016 | 0 | Original | 0008 | 001 | CBER | ||||||||||
|
|
Bayer HealthCare LLC | 125574 | Kovaltry | Antihemophilic Factor (Recombinant), Full Length | 351(a) | 250IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 16, 2016 | 0 | Original | 0008 | 002 | CBER | ||||||||||
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Bayer HealthCare LLC | 125574 | Kovaltry | Antihemophilic Factor (Recombinant), Full Length | 351(a) | 2000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 16, 2016 | 0 | Original | 0008 | 003 | CBER | ||||||||||
|
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Bayer HealthCare LLC | 125574 | Kovaltry | Antihemophilic Factor (Recombinant), Full Length | 351(a) | 3000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 16, 2016 | 0 | Original | 0008 | 004 | CBER | ||||||||||
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Bayer HealthCare LLC | 125574 | Kovaltry | Antihemophilic Factor (Recombinant), Full Length | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 16, 2016 | 0 | Original | 0008 | 005 | CBER | ||||||||||
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Horizon Therapeutics Ireland DAC | 125293 | Krystexxa | pegloticase | 351(a) | 8MG/ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | September 14, 2010 | Original | 2022 | 001 | CDER | September 14, 2017 | ||||||||||
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Horizon Therapeutics Ireland DAC | 125293 | Krystexxa | pegloticase | 351(a) | 8MG/50ML (0.16MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 29, 2025 | 109 | Supplement | 2022 | 002 | CDER | September 14, 2017 | |||||||||
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Novartis Pharmaceuticals Corporation | 125646 | Kymriah | tisagenlecleucel | 351(a) | 0.6 to 6.0 x 10^8 CAR-POSITIVE VIABLE T CELLS | Injection | Intravenous | Bag | Rx | Licensed | August 30, 2017 | 0 | Original | 1244 | 001 | CBER | November 27, 2029 | |||||||||
|
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Chiesi Farmaceutici S.p.A. | 761278 | Lamzede | velmanase alfa-tycv | 351(a) | 10MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 16, 2023 | Original | 2245 | 001 | CDER | February 16, 2030 | ||||||||||
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CellTrans Inc. | 125734 | Lantidra | donislecel-jujn | 351(a) | 1X10E6EQUIVALENT ISLET NUMBER (EIN) | Suspension | Intravenous | Bag | Rx | Licensed | June 28, 2023 | 0 | Original | 2213 | 001 | CBER | ||||||||||
|
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Sanofi-Aventis U.S. LLC | 021081 | Lantus | insulin glargine | 351(a) | 1,000UNITS/10ML (100UNITS/ML) | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | April 20, 2000 | Original | 1752 | 001 | CDER | |||||||||||
|
|
Sanofi-Aventis U.S. LLC | 021081 | Lantus | insulin glargine | 351(a) | 500UNITS/5ML (100UNITS/ML) | Injection | Subcutaneous | Multi-Dose Vial | Disc | Licensed | April 20, 2000 | Original | 1752 | 003 | CDER | |||||||||||
|
|
Sanofi-Aventis U.S. LLC | 021081 | Lantus | insulin glargine | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Multi-Dose Cartridge | Disc | Licensed | April 20, 2000 | Original | 1752 | 004 | CDER | |||||||||||
|
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Sanofi-Aventis U.S. LLC | 021081 | Lantus | insulin glargine | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | April 25, 2007 | 24 | Supplement | 1752 | 002 | CDER | ||||||||||
|
|
Eli Lilly and Company | 761038 | Lartruvo | olaratumab | 351(a) | 500MG/50ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | October 19, 2016 | Original | 1891 | 001 | CDER | February 25, 2020 | ||||||||||
|
|
Eli Lilly and Company | 761038 | Lartruvo | olaratumab | 351(a) | 190MG/19ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | July 10, 2017 | 1 | Supplement | 1891 | 002 | CDER | February 25, 2020 | |||||||||
|
|
Fibrocell Technologies, Inc. | 125348 | Laviv | Azficel-T | 351(a) | 18MU CELL/ML | Injection | Intradermal | Vial | Disc | Licensed | June 21, 2011 | 0 | Original | 1818 | 001 | CBER | ||||||||||
|
|
Genzyme Corporation | 103948 | Lemtrada | alemtuzumab | 351(a) | 12MG/1.2ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 14, 2014 | 5139 | Supplement | 1596 | 002 | CDER | May 7, 2008 | |||||||||
|
|
Orchard Therapeutics (Europe) Ltd. | 125758 | Lenmeldy | atidarsagene autotemcel | 351(a) | 2 x 10^6 to 11.8 x 10^6CELL/ML | Suspension | Intravenous | Bag | Rx | Licensed | March 18, 2024 | 0 | Original | 2263 | 001 | CBER | March 18, 2024 | March 18, 2036 | March 18, 2031 | |||||||
|
|
Eisai, Incorporated | 761269 | Leqembi | lecanemab-irmb | 351(a) | 200MG/2ML (100MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | January 6, 2023 | Original | 1862 | 001 | CDER | |||||||||||
|
|
Eisai, Incorporated | 761269 | Leqembi | lecanemab-irmb | 351(a) | 500MG/5ML (100MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | January 6, 2023 | Original | 1862 | 002 | CDER | |||||||||||
|
|
Eisai, Incorporated | 761375 | Leqembi IQLIK | lecanemab-irmb | 351(a) | 360MG/1.8ML (200MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | August 29, 2025 | Original | 1862 | 001 | CDER | |||||||||||
|
|
LIB Therapeutics, Inc. | 761427 | Lerochol | lerodalcibep-liga | 351(a) | 300MG/1.2ML (250MG/ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | December 12, 2025 | Original | 2352 | 001 | CDER | |||||||||||
|
|
Hugel, Inc. | 761225 | Letybo | letibotulinumtoxinA-wlbg | 351(a) | 50UNITS | For Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | February 29, 2024 | Original | 2237 | 001 | CDER | |||||||||||
|
|
Hugel, Inc. | 761225 | Letybo | letibotulinumtoxinA-wlbg | 351(a) | 100UNITS | For Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | February 29, 2024 | Original | 2237 | 002 | CDER | |||||||||||
|
|
Partner Therapeutics, Inc. | 103362 | Leukine | sargramostim | 351(a) | 250MCG | For Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | March 5, 1991 | Original | 2087 | 001 | CDER | March 29, 2025 | ||||||||||
|
|
Partner Therapeutics, Inc. | 103362 | Leukine | sargramostim | 351(a) | 500MCG/ML | Injection | Intravenous, Subcutaneous | Multi-Dose Vial | Disc | Licensed | March 5, 1991 | Original | 2087 | 002 | CDER | March 29, 2025 | ||||||||||
|
|
Novo Nordisk Inc. | 021536 | Levemir | insulin detemir | 351(a) | 1,000UNITS/10ML (100UNITS/ML) | Injection | Subcutaneous | Multi-Dose Vial | Disc | Licensed | June 16, 2005 | Original | 1261 | 001 | CDER | |||||||||||
|
|
Novo Nordisk Inc. | 021536 | Levemir | insulin detemir | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Disc | Licensed | June 16, 2005 | Original | 1261 | 002 | CDER | |||||||||||
|
|
Novo Nordisk Inc. | 021536 | Levemir | insulin detemir | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Disc | Licensed | June 16, 2005 | Original | 1261 | 003 | CDER | |||||||||||
|
|
Novo Nordisk Inc. | 021536 | Levemir | insulin detemir | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Multi-Dose Cartridge | Disc | Licensed | June 16, 2005 | Original | 1261 | 004 | CDER | |||||||||||
|
|
Novo Nordisk Inc. | 021536 | Levemir | insulin detemir | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Disc | Licensed | October 31, 2013 | 33 | Supplement | 1261 | 005 | CDER | ||||||||||
|
|
Regeneron Pharmaceuticals, Inc. | 761097 | Libtayo | cemiplimab-rwlc | 351(a) | 350MG/7ML (50MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | September 28, 2018 | Original | 1760 | 001 | CDER | |||||||||||
|
|
Immedica Pharma AB | 761211 | Loargys | pegzilarginase-nbln | 351(a) | 2MG/0.4ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | February 23, 2026 | Original | 2342 | 001 | CDER | |||||||||||
|
|
Immedica Pharma AB | 761211 | Loargys | pegzilarginase-nbln | 351(a) | 5MG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | February 23, 2026 | Original | 2342 | 002 | CDER | |||||||||||
|
|
Coherus BioSciences, Inc. | 761240 | Loqtorzi | toripalimab-tpzi | 351(a) | 240MG/6ML (40MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 27, 2023 | Original | 2023 | 001 | CDER | October 27, 2030 | ||||||||||
|
|
Genentech, Inc. | 125156 | Lucentis | ranibizumab | 351(a) | 10MG/ML (0.5MG/0.05ML) | Injection | Intravitreal | Single-Dose Vial | Disc* | Licensed | June 30, 2006 | Original | 1048 | 001 | CDER | Yes | ||||||||||
|
|
Genentech, Inc. | 125156 | Lucentis | ranibizumab | 351(a) | 6MG/ML (0.3MG/0.05ML) | Injection | Intravitreal | Single-Dose Vial | Disc* | Licensed | August 10, 2012 | 76 | Supplement | 1048 | 002 | CDER | Yes | |||||||||
|
|
Genentech, Inc. | 125156 | Lucentis | ranibizumab | 351(a) | 10MG/ML (0.5MG/0.05ML) | Injection | Intravitreal | Pre-Filled Syringe | Rx | Licensed | October 13, 2016 | 110 | Supplement | 1048 | 003 | CDER | Yes | |||||||||
|
|
Genentech, Inc. | 125156 | Lucentis | ranibizumab | 351(a) | 6MG/ML (0.3MG/0.05ML) | Injection | Intravitreal | Pre-Filled Syringe | Rx | Licensed | March 20, 2018 | 117 | Supplement | 1048 | 004 | CDER | Yes | |||||||||
|
|
Genzyme Corporation | 125291 | Lumizyme | alglucosidase alfa | 351(a) | 50MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 24, 2010 | Original | 1596 | 001 | CDER | |||||||||||
|
|
AstraZeneca AB | 761104 | Lumoxiti | moxetumomab pasudotox-tdfk | 351(a) | 1MG | For Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | September 13, 2018 | Original | 2059 | 001 | CDER | September 13, 2025 | ||||||||||
|
|
Genentech, Inc. | 761263 | Lunsumio | mosunetuzumab-axgb | 351(a) | 1MG/ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 22, 2022 | Original | 1048 | 001 | CDER | December 22, 2029 | ||||||||||
|
|
Genentech, Inc. | 761263 | Lunsumio | mosunetuzumab-axgb | 351(a) | 30MG/30ML (1MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 22, 2022 | Original | 1048 | 002 | CDER | December 22, 2029 | ||||||||||
|
|
Genentech, Inc. | 761263 | Lunsumio Velo | mosunetuzumab-axgb | 351(a) | 5MG/0.5ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | December 19, 2025 | 6 | Supplement | 1048 | 003 | CDER | December 22, 2029 | |||||||||
|
|
Genentech, Inc. | 761263 | Lunsumio Velo | mosunetuzumab-axgb | 351(a) | 45MG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | December 19, 2025 | 6 | Supplement | 1048 | 004 | CDER | December 22, 2029 | |||||||||
|
|
Spark Therapeutics, Inc. | 125610 | Luxturna | Voretigene Neparvovec | 351(a) | 1.5X10 TO 11 ML | Injection | Intraocular | Single-Dose Vial | Rx | Licensed | December 19, 2017 | 0 | Original | 2056 | 001 | CBER | December 19, 2024 | |||||||||
|
|
Genetix Biotherapeutics Inc. | 125788 | LYFGENIA | lovotibeglogene autotemcel | 351(a) | 1.7-20x10^6CELL/ML | Suspension | Intravenous | Bag | Rx | Licensed | December 8, 2023 | 0 | Original | 2425 | 001 | CBER | December 8, 2030 | |||||||||
|
|
Citius Pharmaceuticals, Inc. | 761312 | Lymphir | denileukin diftitox-cxdl | 351(a) | 300MCG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 7, 2024 | Original | 2290 | 001 | CDER | |||||||||||
|
|
Regeneron Pharmaceuticals, Inc. | 761400 | Lynozyfic | linvoseltamab-gcpt | 351(a) | 5MG/2.5ML (2MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 2, 2025 | Original | 1760 | 001 | CDER | |||||||||||
|
|
Regeneron Pharmaceuticals, Inc. | 761400 | Lynozyfic | linvoseltamab-gcpt | 351(a) | 200MG/10ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 2, 2025 | Original | 1760 | 002 | CDER | |||||||||||
|
|
Eli Lilly and Company | 761109 | Lyumjev | insulin lispro-aabc | 351(a) | 1,000UNITS/10ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 15, 2020 | Original | 1891 | 001 | CDER | |||||||||||
|
|
Eli Lilly and Company | 761109 | Lyumjev | insulin lispro-aabc | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Autoinjector | Disc | Licensed | June 15, 2020 | Original | 1891 | 002 | CDER | |||||||||||
|
|
Eli Lilly and Company | 761109 | Lyumjev | insulin lispro-aabc | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Autoinjector | Rx | Licensed | June 15, 2020 | Original | 1891 | 003 | CDER | |||||||||||
|
|
Eli Lilly and Company | 761109 | Lyumjev | insulin lispro-aabc | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Autoinjector | Rx | Licensed | June 15, 2020 | Original | 1891 | 004 | CDER | |||||||||||
|
|
Eli Lilly and Company | 761109 | Lyumjev | insulin lispro-aabc | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Multi-Dose Cartridge | Disc | Licensed | June 15, 2020 | Original | 1891 | 005 | CDER | |||||||||||
|
|
Eli Lilly and Company | 761109 | Lyumjev | insulin lispro-aabc | 351(a) | 600UNITS/3ML (200UNITS/ML) | Injection | Intravenous, Subcutaneous | Autoinjector | Rx | Licensed | June 15, 2020 | Original | 1891 | 006 | CDER | |||||||||||
|
|
Merck Sharp & Dohme LLC | 101069 | M-M-R Ii | Measles, Mumps and Rubella Virus Vaccine Live | 351(a) | 0.5ML | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | April 22, 1971 | 0 | Original | 0002 | 001 | CBER | ||||||||||
|
|
Merck Sharp & Dohme LLC | 101069 | M-M-R Ii | Measles, Mumps and Rubella Virus Vaccine Live | 351(a) | 0.5ML | For Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | February 27, 2023 | 5846 | Supplement | 0002 | 002 | CBER | ||||||||||
|
|
Vericel Corporation | 125603 | Maci | autologous cultured chondrocytes on porcine collagen membrane | 351(a) | 500,000 CM2 CM2 | Cell Sheets | Implantation | Pouch | Rx | Licensed | December 13, 2016 | 0 | Original | 2010 | 001 | CBER | ||||||||||
|
|
Bracco Diagnostics Inc. | 017833 | Macrotec | kit for the preparation of technetium Tc-99m albumin aggregated | 351(a) | 1.5MG/10MG/0.07MG/0.19MG/1.8MG | For Injectable Suspension | Intravenous | Vial | Disc | Licensed | February 23, 1976 | Original | 2183 | 001 | CDER | |||||||||||
|
|
MacroGenics Inc. | 761150 | Margenza | margetuximab-cmkb | 351(a) | 250MG/10ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 16, 2020 | Original | 2139 | 001 | CDER | |||||||||||
|
|
Iso-Tex Diagnostics, Inc. | 017837 | Megatope | iodinated I-131 albumin | 351(a) | 0.5mCi | Injection | Intravenous | Multi-Dose Vial | Disc | Licensed | February 23, 1976 | Original | 2189 | 001 | CDER | |||||||||||
|
|
Iso-Tex Diagnostics, Inc. | 017837 | Megatope | iodinated I-131 albumin | 351(a) | 1mCi | Injection | Intravenous | Multi-Dose Vial | Rx | Licensed | February 23, 1976 | Original | 2189 | 002 | CDER | |||||||||||
|
|
Iso-Tex Diagnostics, Inc. | 017837 | Megatope | iodinated I-131 albumin | 351(a) | 2mCi | Injection | Intravenous | Multi-Dose Vial | Disc | Licensed | February 23, 1976 | Original | 2189 | 003 | CDER | |||||||||||
|
|
Iso-Tex Diagnostics, Inc. | 017837 | Megatope | iodinated I-131 albumin | 351(a) | 5uCi/AMP | Injection | Intravenous | Multi-Dose Vial | Disc | Licensed | February 23, 1976 | Original | 2189 | 004 | CDER | |||||||||||
|
|
Iso-Tex Diagnostics, Inc. | 017837 | Megatope | iodinated I-131 albumin | 351(a) | 20uCi/AMP | Injection | Intravenous | Multi-Dose Vial | Disc | Licensed | February 23, 1976 | Original | 2189 | 005 | CDER | |||||||||||
|
|
Sanofi Pasteur Inc. | 125089 | Menactra | Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine | 351(a) | 48UG/.5ML | For Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | January 14, 2005 | 0 | Original | 1725 | 001 | CBER | ||||||||||
|
|
GlaxoSmithKline Biologicals | 125363 | MENHIBRIX | Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine | 351(a) | 0.5ML | Injection | Intramuscular | Vial | Disc | Voluntarily Revoked | June 14, 2012 | 0 | Original | 1617 | 001 | CBER | ||||||||||
|
|
Sanofi Pasteur Inc. | 103926 | Menomune | Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined | 351(a) | 50UG/.5ML | For Injection | Subcutaneous | Vial | Disc | Voluntarily Revoked | December 9, 1999 | 0 | Original | 1725 | 001 | CBER | ||||||||||
|
|
Sanofi Pasteur Inc. | 103924 | Menomune-A | Meningococcal Polysaccharide Vaccine, Group A | 351(a) | 0.5ML | For Injection | Subcutaneous | Vial | Disc | Voluntarily Revoked | December 9, 1999 | 0 | Original | 1725 | 001 | CBER | ||||||||||
|
|
Sanofi Pasteur Inc. | 103925 | Menomune-A/C | Meningococcal Polysaccharide Vaccine, Groups A and C Combined | 351(a) | 50UG/.5ML | For Injection | Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | December 9, 1999 | 0 | Original | 1725 | 001 | CBER | ||||||||||
|
|
Sanofi Pasteur Inc. | 103925 | Menomune-A/C | Meningococcal Polysaccharide Vaccine, Groups A and C Combined | 351(a) | 50UG/.5ML | For Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | December 9, 1999 | 0 | Original | 1725 | 002 | CBER | ||||||||||
|
|
Sanofi Pasteur Inc. | 103923 | Menomune-C | Meningococcal Polysaccharide Vaccine, Group C | 351(a) | 0.5ML | For Injection | Subcutaneous | Vial | Disc | Voluntarily Revoked | December 9, 1999 | 0 | Original | 1725 | 001 | CBER | ||||||||||
|
|
Ferring Pharmaceuticals Inc. | 021663 | Menopur | menotropins | 351(a) | 75IU | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | October 29, 2004 | Original | 2112 | 001 | CDER | |||||||||||
|
|
Sanofi Pasteur Inc. | 125701 | Menquadfi | Meningococcal (Groups A, C, Y, W) Conjugate Vaccine | 351(a) | 0.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | April 23, 2020 | 0 | Original | 1725 | 001 | CBER | April 23, 2020 | April 23, 2032 | ||||||||
|
|
GlaxoSmithKline Biologicals | 125300 | Menveo | Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine | 351(a) | 0.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | February 19, 2010 | 0 | Original | 1617 | 001 | CBER | ||||||||||
|
|
GlaxoSmithKline Biologicals | 125300 | Menveo | Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine | 351(a) | 0.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | October 14, 2022 | 778 | Supplement | 1617 | 002 | CBER | ||||||||||
|
|
Ultragenyx Pharamceutical Inc. | 761047 | Mepsevii | vestronidase alfa-vjbk | 351(a) | 10MG/5ML (2MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 15, 2017 | Original | 2040 | 001 | CDER | November 15, 2024 | ||||||||||
|
|
Sanofi-Aventis U.S. LLC | 761325 | Merilog | insulin aspart-szjj | 351(k) Biosimilar | 1,000UNITS/10ML (100UNITS/ML) | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | February 14, 2025 | insulin aspart | Novolog | Original | 1752 | 001 | CDER | |||||||||
|
|
Sanofi-Aventis U.S. LLC | 761325 | Merilog | insulin aspart-szjj | 351(k) Biosimilar | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | February 14, 2025 | insulin aspart | Novolog | Original | 1752 | 002 | CDER | |||||||||
|
|
Merck Sharp & Dohme LLC | 101075 | MERUVAX II | Rubella Virus Vaccine Live | 351(a) | NLT1000U/.5ML | For Injection | Subcutaneous | Vial | Disc | Voluntarily Revoked | June 9, 1969 | 0 | Original | 0002 | 001 | CBER | ||||||||||
|
|
Kedrion Biopharma Inc. | 103777 | Micrhogam, Rhogam | Rho(D) Immune Globulin (Human) | 351(a) | 50UG | Injection | Intramuscular | Pre-Filled Syringe | Disc | Licensed | April 23, 1998 | 0 | Original | 1906 | 001 | CBER | ||||||||||
|
|
Kedrion Biopharma Inc. | 103777 | Micrhogam, Rhogam | Rho(D) Immune Globulin (Human) | 351(a) | 300UG | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | April 23, 1998 | 0 | Original | 1906 | 002 | CBER | ||||||||||
|
|
Pharmalucence Inc | 018263 | Microlite | radiolabeled albumin technetium Tc-99m albumin colloid kit | 351(a) | Single-Dose Vial | Disc | Voluntarily Revoked | March 25, 1983 | Original | 2203 | 001 | CDER | ||||||||||||||
|
|
Vifor (International) Inc. | 125164 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 50MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | November 14, 2007 | Original | 2039 | 002 | CDER | |||||||||||
|
|
Vifor (International) Inc. | 125164 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 75MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | November 14, 2007 | Original | 2039 | 003 | CDER | |||||||||||
|
|
Vifor (International) Inc. | 125164 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 100MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | November 14, 2007 | Original | 2039 | 004 | CDER | |||||||||||
|
|
Vifor (International) Inc. | 125164 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 150MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | November 14, 2007 | Original | 2039 | 006 | CDER | |||||||||||
|
|
Vifor (International) Inc. | 125164 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 200MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | November 14, 2007 | Original | 2039 | 007 | CDER | |||||||||||
|
|
Vifor (International) Inc. | 125164 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 250MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | November 14, 2007 | Original | 2039 | 008 | CDER | |||||||||||
|
|
Vifor (International) Inc. | 125164 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 50MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | November 14, 2007 | Original | 2039 | 010 | CDER | |||||||||||
|
|
Vifor (International) Inc. | 125164 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 100MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | November 14, 2007 | Original | 2039 | 011 | CDER | |||||||||||
|
|
Vifor (International) Inc. | 125164 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 200MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | November 14, 2007 | Original | 2039 | 012 | CDER | |||||||||||
|
|
Vifor (International) Inc. | 125164 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 300MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | November 14, 2007 | Original | 2039 | 013 | CDER | |||||||||||
|
|
Vifor (International) Inc. | 125164 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 400MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | November 14, 2007 | Original | 2039 | 014 | CDER | |||||||||||
|
|
Vifor (International) Inc. | 125164 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 600MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | November 14, 2007 | Original | 2039 | 015 | CDER | |||||||||||
|
|
Vifor (International) Inc. | 125164 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 1,000MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | November 14, 2007 | Original | 2039 | 016 | CDER | |||||||||||
|
|
Vifor (International) Inc. | 125164 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 400MCG/0.6ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Disc | Licensed | November 14, 2007 | Original | 2039 | 017 | CDER | |||||||||||
|
|
Vifor (International) Inc. | 125164 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 600MCG/0.6ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Disc | Licensed | November 14, 2007 | Original | 2039 | 018 | CDER | |||||||||||
|
|
Vifor (International) Inc. | 125164 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 800MCG/0.6ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Disc | Licensed | November 14, 2007 | Original | 2039 | 019 | CDER | |||||||||||
|
|
Vifor (International) Inc. | 125164 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 30MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | April 28, 2016 | 73 | Supplement | 2039 | 001 | CDER | ||||||||||
|
|
Vifor (International) Inc. | 125164 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 120MCG/0.3ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | April 28, 2016 | 73 | Supplement | 2039 | 005 | CDER | ||||||||||
|
|
Vifor (International) Inc. | 125164 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | 360MCG/0.6ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | April 28, 2016 | 73 | Supplement | 2039 | 009 | CDER | ||||||||||
|
|
ModernaTX, Inc. | 125835 | mnexspike | COVID-19 Vaccine, mRNA | 351(a) | 10UG | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | May 30, 2025 | 0 | Original | 2256 | 001 | CBER | ||||||||||
|
|
Incyte Corporation | 761163 | Monjuvi | tafasitamab-cxix | 351(a) | 200MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 31, 2020 | Original | 2228 | 001 | CDER | July 31, 2027 | ||||||||||
|
|
CSL Behring LLC | 103953 | Monoclate, Monoclate-P | Antihemophilic Factor (Human) | 351(a) | 500IU | For Injection | Intravenous | Vial | Disc | Voluntarily Revoked | May 14, 2003 | 1000 | Supplement | 1767 | 001 | CBER | ||||||||||
|
|
CSL Behring LLC | 103953 | Monoclate, Monoclate-P | Antihemophilic Factor (Human) | 351(a) | 1000IU | For Injection | Intravenous | Vial | Disc | Voluntarily Revoked | May 14, 2003 | 1000 | Supplement | 1767 | 002 | CBER | ||||||||||
|
|
CSL Behring LLC | 103953 | Monoclate, Monoclate-P | Antihemophilic Factor (Human) | 351(a) | 250IU | For Injection | Intravenous | Vial | Disc | Voluntarily Revoked | May 14, 2003 | 1000 | Supplement | 1767 | 003 | CBER | ||||||||||
|
|
CSL Behring LLC | 103953 | Monoclate, Monoclate-P | Antihemophilic Factor (Human) | 351(a) | 1500IU | For Injection | Intravenous | Vial | Disc | Voluntarily Revoked | March 4, 2004 | 5074 | Supplement | 1767 | 004 | CBER | ||||||||||
|
|
CSL Behring LLC | 103957 | Mononine | Coagulation Factor IX (Human) | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | March 17, 2000 | 0 | Original | 1767 | 001 | CBER | August 20, 1999 | |||||||||
|
|
CSL Behring LLC | 103957 | Mononine | Coagulation Factor IX (Human) | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | March 17, 2000 | 0 | Original | 1767 | 002 | CBER | August 20, 1999 | |||||||||
|
|
ModernaTX, Inc. | 125796 | mresvia | Respiratory Syncytial Virus Vaccine | 351(a) | 50UG/.5ML | For Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | May 31, 2024 | 0 | Original | 2256 | 001 | CBER | May 31, 2024 | May 31, 2036 | ||||||||
|
|
Merck Sharp & Dohme LLC | 101072 | MumpsVax | Mumps Virus Vaccine Live | 351(a) | 0.5ML | For Injection | Subcutaneous | Vial | Disc | Voluntarily Revoked | December 28, 1967 | 0 | Original | 0002 | 001 | CBER | ||||||||||
|
|
Amgen Inc. | 761028 | Mvasi | bevacizumab-awwb | 351(k) Biosimilar | 100MG/4ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | September 14, 2017 | bevacizumab | Avastin | Original | 1080 | 001 | CDER | |||||||||
|
|
Amgen Inc. | 761028 | Mvasi | bevacizumab-awwb | 351(k) Biosimilar | 400MG/16ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | September 14, 2017 | bevacizumab | Avastin | Original | 1080 | 002 | CDER | |||||||||
|
|
Chiesi Farmaceutici S.p.A. | 125390 | Myalept | metreleptin | 351(a) | 11.3MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | February 24, 2014 | Original | 2245 | 001 | CDER | February 24, 2021 | ||||||||||
|
|
Sanofi Pasteur Limited | 103942 | Mycobax | BCG Vaccine | 351(a) | 1.5MG | For Injection | Intradermal | Multi-Dose Vial | Rx | Voluntarily Revoked | February 24, 2000 | 0 | Original | 1726 | 001 | CBER | ||||||||||
|
|
Wyeth Pharmaceuticals LLC | 761060 | Mylotarg | gemtuzumab ozogamicin | 351(a) | 4.5MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | September 1, 2017 | Original | 0003 | 001 | CDER | September 1, 2024 | ||||||||||
|
|
Solstice NeuroSciences, LLC | 103846 | Myobloc | rimabotulinumtoxinB | 351(a) | 2,500UNITS/0.5ML | Injection | Intramuscular, Intraglandular | Single-Dose Vial | Rx | Licensed | December 8, 2000 | Original | 1718 | 001 | CDER | December 8, 2007 | ||||||||||
|
|
Solstice NeuroSciences, LLC | 103846 | Myobloc | rimabotulinumtoxinB | 351(a) | 5,000UNITS/ML | Injection | Intramuscular, Intraglandular | Single-Dose Vial | Rx | Licensed | December 8, 2000 | Original | 1718 | 002 | CDER | December 8, 2007 | ||||||||||
|
|
Solstice NeuroSciences, LLC | 103846 | Myobloc | rimabotulinumtoxinB | 351(a) | 10,000UNITS/2ML (5,000UNITS/ML) | Injection | Intramuscular, Intraglandular | Single-Dose Vial | Rx | Licensed | December 8, 2000 | Original | 1718 | 003 | CDER | December 8, 2007 | ||||||||||
|
|
Genzyme Corporation | 125141 | Myozyme | alglucosidase alfa | 351(a) | 50MG | For Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | April 28, 2006 | Original | 1596 | 001 | CDER | April 28, 2013 | ||||||||||
|
|
Baxter Healthcare Corporation | 208157 | Myxredlin | insulin human | 351(a) | 100UNITS/100ML (1UNIT/ML) | Injection | Intravenous | Single-Dose Container | Rx | Licensed | June 20, 2019 | Original | 140 | 001 | CDER | |||||||||||
|
|
Akeso Biopharma Co., Ltd. | 761258 | N/A | penpulimab-kcqx | 351(a) | 100MG/10ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 23, 2025 | Original | 2253 | 001 | CDER | |||||||||||
|
|
ALK-Abello, Inc. | 103752 | N/A | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 001 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103752 | N/A | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 002 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103810 | N/A | Animal Allergens, Standardized Cat Hair | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | December 16, 1971 | 0 | Original | 1256 | 001 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103810 | N/A | Animal Allergens, Standardized Cat Hair | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | December 16, 1971 | 0 | Original | 1256 | 002 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103051 | N/A | Pollens - Grasses, Bermuda Grass Cynodon dactylon | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1958 | 0 | Original | 1256 | 001 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103051 | N/A | Pollens - Grasses, Bermuda Grass Cynodon dactylon | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1958 | 0 | Original | 1256 | 002 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103052 | N/A | Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 001 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103052 | N/A | Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 002 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103052 | N/A | Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 003 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103052 | N/A | Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 004 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103053 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 001 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103053 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 002 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103053 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 003 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103053 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 004 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103054 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 001 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103054 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 002 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103054 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 003 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103054 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 004 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103055 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 001 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103055 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 002 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103055 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 003 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103055 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 004 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103056 | N/A | Pollens - Grasses, Ryegrass, Perennial Lolium perenne | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 001 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103056 | N/A | Pollens - Grasses, Ryegrass, Perennial Lolium perenne | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 002 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103057 | N/A | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 001 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103057 | N/A | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 002 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103058 | N/A | Pollens - Grasses, Timothy Phleum pratense | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 001 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103058 | N/A | Pollens - Grasses, Timothy Phleum pratense | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 002 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103059 | N/A | Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia | 351(a) | 1:20W/V | Injection | Percutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 001 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103059 | N/A | Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia | 351(a) | 1:20W/V | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 002 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103060 | N/A | Insects (Whole Body), Mite Dermatophagoides farinae | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 001 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103060 | N/A | Insects (Whole Body), Mite Dermatophagoides farinae | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | September 29, 1950 | 0 | Original | 1256 | 002 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103061 | N/A | Animal Allergens, Standardized Cat Pelt | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Voluntarily Revoked | September 29, 1950 | 0 | Original | 1256 | 001 | CBER | ||||||||||
|
|
ALK-Abello, Inc. | 103061 | N/A | Animal Allergens, Standardized Cat Pelt | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Voluntarily Revoked | September 29, 1950 | 0 | Original | 1256 | 002 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101377 | N/A | Insects (Whole Body), Mite Dermatophagoides farinae | 351(a) | 10,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | July 11, 1930 | 0 | Original | 0103 | 001 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101377 | N/A | Insects (Whole Body), Mite Dermatophagoides farinae | 351(a) | 10,000AU/ML | Injection | Percutaneous | Dropper Vial | Disc | Voluntarily Revoked | July 11, 1930 | 0 | Original | 0103 | 002 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101378 | N/A | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 10,000AU/ML | Injection | Percutaneous | Dropper Vial | Disc | Voluntarily Revoked | July 11, 1930 | 0 | Original | 0103 | 001 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101378 | N/A | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 10,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | July 11, 1930 | 0 | Original | 0103 | 002 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101379 | N/A | Pollens - Grasses, Bermuda Grass Cynodon dactylon | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 001 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101379 | N/A | Pollens - Grasses, Bermuda Grass Cynodon dactylon | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 002 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101380 | N/A | Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 001 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101380 | N/A | Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 002 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101380 | N/A | Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 003 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101380 | N/A | Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 004 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101381 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 001 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101381 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 002 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101381 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 003 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101381 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 004 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101382 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 001 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101382 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 002 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101382 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 003 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101382 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | May 29, 1997 | 0 | Original | 0103 | 004 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101383 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 001 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101383 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 002 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101383 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 003 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101383 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 004 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101384 | N/A | Pollens - Grasses, Ryegrass, Perennial Lolium perenne | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 001 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101384 | N/A | Pollens - Grasses, Ryegrass, Perennial Lolium perenne | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 002 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101384 | N/A | Pollens - Grasses, Ryegrass, Perennial Lolium perenne | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 003 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101384 | N/A | Pollens - Grasses, Ryegrass, Perennial Lolium perenne | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | June 25, 1997 | 0 | Original | 0103 | 004 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101385 | N/A | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 001 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101385 | N/A | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 002 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101385 | N/A | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 003 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101385 | N/A | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 004 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101386 | N/A | Pollens - Grasses, Timothy Phleum pratense | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 001 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101386 | N/A | Pollens - Grasses, Timothy Phleum pratense | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 002 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101386 | N/A | Pollens - Grasses, Timothy Phleum pratense | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 003 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101386 | N/A | Pollens - Grasses, Timothy Phleum pratense | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 004 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101387 | N/A | Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia | 351(a) | 1:10W/V | Injection | Percutaneous | Dropper Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 001 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101387 | N/A | Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia | 351(a) | 1:10W/V | Injection | Intradermal | Multi-Dose Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 002 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 101387 | N/A | Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia | 351(a) | 1:10W/V | Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | June 14, 1930 | 0 | Original | 0103 | 003 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 103324 | N/A | Animal Allergens, Standardized Cat Hair | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Disc | Voluntarily Revoked | July 11, 1930 | 0 | Original | 0103 | 001 | CBER | ||||||||||
|
|
Allergy Laboratories, Inc. | 103324 | N/A | Animal Allergens, Standardized Cat Hair | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | July 11, 1930 | 0 | Original | 0103 | 002 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 103473 | N/A | Animal Allergens, Standardized Cat Hair | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 001 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 103473 | N/A | Animal Allergens, Standardized Cat Hair | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 002 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 103113 | N/A | Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia | 351(a) | 1:10W/V | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1974 | 0 | Original | 0467 | 001 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 103113 | N/A | Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia | 351(a) | 1:10W/V | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 13, 1974 | 0 | Original | 0467 | 002 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102212 | N/A | Insects (Whole Body), Mite Dermatophagoides farinae | 351(a) | 5,000AU/ML | Injection | Intradermal | Dropper Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 001 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102212 | N/A | Insects (Whole Body), Mite Dermatophagoides farinae | 351(a) | 5,000AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 002 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102212 | N/A | Insects (Whole Body), Mite Dermatophagoides farinae | 351(a) | 5,000AU/ML | Injection | Subcutaneous | Dropper Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 003 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102212 | N/A | Insects (Whole Body), Mite Dermatophagoides farinae | 351(a) | 5,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 004 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102212 | N/A | Insects (Whole Body), Mite Dermatophagoides farinae | 351(a) | 10,000AU/ML | Injection | Intradermal | Dropper Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 005 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102212 | N/A | Insects (Whole Body), Mite Dermatophagoides farinae | 351(a) | 10,000AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 006 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102212 | N/A | Insects (Whole Body), Mite Dermatophagoides farinae | 351(a) | 10,000AU/ML | Injection | Subcutaneous | Dropper Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 007 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102212 | N/A | Insects (Whole Body), Mite Dermatophagoides farinae | 351(a) | 10,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 008 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102213 | N/A | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 5,000AU/ML | Injection | Intradermal | Dropper Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 001 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102213 | N/A | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 5,000AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 002 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102213 | N/A | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 5,000AU/ML | Injection | Subcutaneous | Dropper Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 003 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102213 | N/A | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 5,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 004 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102213 | N/A | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 10,000AU/ML | Injection | Intradermal | Dropper Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 005 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102213 | N/A | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 10,000AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 006 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102213 | N/A | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 10,000AU/ML | Injection | Subcutaneous | Dropper Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 007 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102213 | N/A | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 10,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 008 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102214 | N/A | Pollens - Grasses, Bermuda Grass Cynodon dactylon | 351(a) | 10,000BAU/ML | Injection | Intradermal | Dropper Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0467 | 001 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102214 | N/A | Pollens - Grasses, Bermuda Grass Cynodon dactylon | 351(a) | 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0467 | 002 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102214 | N/A | Pollens - Grasses, Bermuda Grass Cynodon dactylon | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Dropper Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0467 | 003 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102214 | N/A | Pollens - Grasses, Bermuda Grass Cynodon dactylon | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0467 | 004 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102215 | N/A | Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis | 351(a) | 10,000BAU/ML | Injection | Intradermal | Dropper Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0467 | 001 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102215 | N/A | Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis | 351(a) | 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0467 | 002 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102215 | N/A | Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Dropper Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0467 | 003 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102215 | N/A | Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0467 | 004 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102215 | N/A | Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis | 351(a) | 100,000BAU/ML | Injection | Intradermal | Dropper Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0467 | 005 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102215 | N/A | Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis | 351(a) | 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0467 | 006 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102215 | N/A | Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Dropper Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0467 | 007 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102215 | N/A | Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0467 | 008 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102216 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 10,000BAU/ML | Injection | Intradermal | Dropper Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 001 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102216 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 002 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102216 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Dropper Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 003 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102216 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 004 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102216 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 100,000BAU/ML | Injection | Intradermal | Dropper Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 005 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102216 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 006 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102216 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Dropper Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 007 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102216 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 008 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102217 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 001 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102217 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 10,000BAU/ML | Injection | Intradermal | Dropper Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 002 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102217 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 003 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102217 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Dropper Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 004 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102217 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 005 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102217 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 100,000BAU/ML | Injection | Intradermal | Dropper Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 006 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102217 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 007 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102217 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Dropper Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 008 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102218 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 001 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102218 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 10,000BAU/ML | Injection | Intradermal | Dropper Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 002 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102218 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 003 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102218 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Dropper Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 004 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102218 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 005 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102218 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 100,000BAU/ML | Injection | Intradermal | Dropper Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 006 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102218 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 007 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102218 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Dropper Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 008 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102219 | N/A | Pollens - Grasses, Ryegrass, Perennial Lolium perenne | 351(a) | 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 001 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102219 | N/A | Pollens - Grasses, Ryegrass, Perennial Lolium perenne | 351(a) | 10,000BAU/ML | Injection | Intradermal | Dropper Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0467 | 002 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102219 | N/A | Pollens - Grasses, Ryegrass, Perennial Lolium perenne | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0467 | 003 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102219 | N/A | Pollens - Grasses, Ryegrass, Perennial Lolium perenne | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Dropper Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0467 | 004 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102219 | N/A | Pollens - Grasses, Ryegrass, Perennial Lolium perenne | 351(a) | 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0467 | 005 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102219 | N/A | Pollens - Grasses, Ryegrass, Perennial Lolium perenne | 351(a) | 100,000BAU/ML | Injection | Intradermal | Dropper Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0467 | 006 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102219 | N/A | Pollens - Grasses, Ryegrass, Perennial Lolium perenne | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0467 | 007 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102219 | N/A | Pollens - Grasses, Ryegrass, Perennial Lolium perenne | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Dropper Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0467 | 008 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102220 | N/A | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | 10,000BAU/ML | Injection | Intradermal | Dropper Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 001 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102220 | N/A | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 002 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102220 | N/A | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Dropper Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 003 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102220 | N/A | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 004 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102220 | N/A | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | 100,000BAU/ML | Injection | Intradermal | Dropper Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 005 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102220 | N/A | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 006 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102220 | N/A | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Dropper Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 007 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102220 | N/A | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 12, 1974 | 0 | Original | 0467 | 008 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102221 | N/A | Pollens - Grasses, Timothy Phleum pratense | 351(a) | 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0467 | 001 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102221 | N/A | Pollens - Grasses, Timothy Phleum pratense | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0467 | 002 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102221 | N/A | Pollens - Grasses, Timothy Phleum pratense | 351(a) | 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0467 | 003 | CBER | ||||||||||
|
|
Allermed Laboratories, Inc. | 102221 | N/A | Pollens - Grasses, Timothy Phleum pratense | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0467 | 004 | CBER | ||||||||||
|
|
Bloodworks | 125585 | N/A | HPC, Cord Blood | 351(a) | 5X10^8 NUCLEATED CELLS CONTENT WITH 85% VIABILITY & 1.25X10^6 VIABLE CD34+ CELLS (PRE-CRYOPRESERVATION) | Injection | Intravenous | Bag | Rx | Licensed | January 28, 2016 | 0 | Original | 2042 | 001 | CBER | ||||||||||
|
|
Central Laboratory of the Netherlands Red Cross Blood Transfusion Service | 101993 | N/A | Albumin (Human) | 351(a) | 25% | Injection | Intravenous | Multi-Dose Vial | Rx | Licensed | September 7, 1979 | 0 | Original | 0379 | 001 | CBER | ||||||||||
|
|
Clinimmune Labs | 125391 | N/A | HPC, Cord Blood | 351(a) | 5X10^8 TOTAL NUCLEATED CELLS WITH AT LEAST 1.25X10^6 VIABLE CD34+ CELLS | Injection | Intravenous | Bag | Rx | Licensed | May 24, 2012 | 0 | Original | 1855 | 001 | CBER | ||||||||||
|
|
Emergent Manufacturing Operations Baltimore LLC | 125349 | N/A | raxibacumab | 351(a) | 1,700MG/34ML (50MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 14, 2012 | Original | 2083 | 001 | CDER | December 14, 2019 | ||||||||||
|
|
Greer Laboratories, Inc. | 101834 | N/A | Insects (Whole Body), Mite Dermatophagoides farinae | 351(a) | 10,000AU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 001 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101834 | N/A | Insects (Whole Body), Mite Dermatophagoides farinae | 351(a) | 5,000AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 002 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101834 | N/A | Insects (Whole Body), Mite Dermatophagoides farinae | 351(a) | 5,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 003 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101834 | N/A | Insects (Whole Body), Mite Dermatophagoides farinae | 351(a) | 10,000AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 004 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101834 | N/A | Insects (Whole Body), Mite Dermatophagoides farinae | 351(a) | 10,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 005 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101834 | N/A | Insects (Whole Body), Mite Dermatophagoides farinae | 351(a) | 30,000AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 006 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101834 | N/A | Insects (Whole Body), Mite Dermatophagoides farinae | 351(a) | 30,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 007 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101835 | N/A | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 10,000AU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 001 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101835 | N/A | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 5,000AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 002 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101835 | N/A | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 5,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 003 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101835 | N/A | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 10,000AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 004 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101835 | N/A | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 10,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 005 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101835 | N/A | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 30,000AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 006 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101835 | N/A | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 30,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 007 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101836 | N/A | Pollens - Grasses, Bermuda Grass Cynodon dactylon | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 001 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101836 | N/A | Pollens - Grasses, Bermuda Grass Cynodon dactylon | 351(a) | 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 002 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101836 | N/A | Pollens - Grasses, Bermuda Grass Cynodon dactylon | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 003 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101836 | N/A | Pollens - Grasses, Bermuda Grass Cynodon dactylon | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 004 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101836 | N/A | Pollens - Grasses, Bermuda Grass Cynodon dactylon | 351(a) | 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 005 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101836 | N/A | Pollens - Grasses, Bermuda Grass Cynodon dactylon | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 006 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101837 | N/A | Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 001 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101837 | N/A | Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis | 351(a) | 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 002 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101837 | N/A | Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 003 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101838 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 001 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101838 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 002 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101838 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 003 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101838 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 004 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101838 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 005 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101838 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 006 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101839 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 001 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101839 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 002 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101839 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 003 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101839 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 004 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101839 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 005 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101839 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 006 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101840 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 001 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101840 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 002 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101840 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 003 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101840 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 004 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101840 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 005 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101840 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 006 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101841 | N/A | Pollens - Grasses, Ryegrass, Perennial Lolium perenne | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 001 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101841 | N/A | Pollens - Grasses, Ryegrass, Perennial Lolium perenne | 351(a) | 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 002 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101841 | N/A | Pollens - Grasses, Ryegrass, Perennial Lolium perenne | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 003 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101841 | N/A | Pollens - Grasses, Ryegrass, Perennial Lolium perenne | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 004 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101841 | N/A | Pollens - Grasses, Ryegrass, Perennial Lolium perenne | 351(a) | 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 005 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101841 | N/A | Pollens - Grasses, Ryegrass, Perennial Lolium perenne | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 006 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101842 | N/A | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 001 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101842 | N/A | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 002 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101842 | N/A | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 003 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101842 | N/A | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 004 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101842 | N/A | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 005 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101842 | N/A | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 006 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101843 | N/A | Pollens - Grasses, Timothy Phleum pratense | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 001 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101843 | N/A | Pollens - Grasses, Timothy Phleum pratense | 351(a) | 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 002 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101843 | N/A | Pollens - Grasses, Timothy Phleum pratense | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 003 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101843 | N/A | Pollens - Grasses, Timothy Phleum pratense | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 004 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101843 | N/A | Pollens - Grasses, Timothy Phleum pratense | 351(a) | 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 005 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101843 | N/A | Pollens - Grasses, Timothy Phleum pratense | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 006 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101844 | N/A | Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia | 351(a) | 1:20W/V | Injection | Percutaneous | Dropper Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 001 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101844 | N/A | Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia | 351(a) | 1:20W/V | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 002 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101844 | N/A | Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia | 351(a) | 1:20W/V | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 14, 1930 | 0 | Original | 0308 | 003 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101845 | N/A | Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia elatior | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 001 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101845 | N/A | Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia elatior | 351(a) | 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 002 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101845 | N/A | Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia elatior | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 003 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101845 | N/A | Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia elatior | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 004 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101845 | N/A | Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia elatior | 351(a) | 100,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 005 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 101845 | N/A | Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia elatior | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 006 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 103397 | N/A | Animal Allergens, Standardized Cat Hair | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 001 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 103397 | N/A | Animal Allergens, Standardized Cat Hair | 351(a) | 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 002 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 103397 | N/A | Animal Allergens, Standardized Cat Hair | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 003 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 103397 | N/A | Animal Allergens, Standardized Cat Hair | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 004 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 103397 | N/A | Animal Allergens, Standardized Cat Hair | 351(a) | 5,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 005 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 103397 | N/A | Animal Allergens, Standardized Cat Hair | 351(a) | 5,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 006 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 103397 | N/A | Animal Allergens, Standardized Cat Hair | 351(a) | 5,000BAU/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | Licensed | September 15, 1958 | 0 | Original | 0308 | 007 | CBER | ||||||||||
|
|
Greer Laboratories, Inc. | 103569 | N/A | Plague Vaccine | 351(a) | 2BIL. CELL/ML | Injection | Intramuscular | Single-Dose Vial | Disc | Licensed | October 5, 1994 | 0 | Original | 0308 | 001 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103870 | N/A | Insects (Whole Body), Mite Dermatophagoides farinae | 351(a) | 10,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 001 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103870 | N/A | Insects (Whole Body), Mite Dermatophagoides farinae | 351(a) | 30AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 002 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103870 | N/A | Insects (Whole Body), Mite Dermatophagoides farinae | 351(a) | 30,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 003 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103870 | N/A | Insects (Whole Body), Mite Dermatophagoides farinae | 351(a) | 300AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 004 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103870 | N/A | Insects (Whole Body), Mite Dermatophagoides farinae | 351(a) | 30,000AU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 005 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103871 | N/A | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 10,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 001 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103871 | N/A | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 30AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 002 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103871 | N/A | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 30,000AU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 003 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103871 | N/A | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 300AU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 004 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103871 | N/A | Insects (Whole Body), Mite Dermatophagoides pteronyssinus | 351(a) | 30,000AU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 005 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103872 | N/A | Pollens - Grasses, Bermuda Grass Cynodon dactylon | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 001 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103872 | N/A | Pollens - Grasses, Bermuda Grass Cynodon dactylon | 351(a) | 100BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 002 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103872 | N/A | Pollens - Grasses, Bermuda Grass Cynodon dactylon | 351(a) | 1,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 003 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103872 | N/A | Pollens - Grasses, Bermuda Grass Cynodon dactylon | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 004 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103873 | N/A | Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 001 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103873 | N/A | Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis | 351(a) | 100BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 002 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103873 | N/A | Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 003 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103873 | N/A | Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis | 351(a) | 1,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 004 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103873 | N/A | Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 005 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103873 | N/A | Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 006 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103874 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 001 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103874 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 100BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 002 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103874 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 003 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103874 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 1,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 004 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103874 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 005 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103874 | N/A | Pollens - Grasses, Fescue, Meadow Festuca elatior | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 006 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103875 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 001 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103875 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 100BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 002 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103875 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 003 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103875 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 1,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 004 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103875 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 005 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103875 | N/A | Pollens - Grasses, Orchard Grass Dactylis glomerata | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 006 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103876 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 001 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103876 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 100BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 002 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103876 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 003 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103876 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 1,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 004 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103876 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 005 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103876 | N/A | Pollens - Grasses, Redtop Agrostis alba | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 006 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103877 | N/A | Pollens - Grasses, Ryegrass, Perennial Lolium perenne | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 001 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103877 | N/A | Pollens - Grasses, Ryegrass, Perennial Lolium perenne | 351(a) | 100BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 002 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103877 | N/A | Pollens - Grasses, Ryegrass, Perennial Lolium perenne | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 003 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103877 | N/A | Pollens - Grasses, Ryegrass, Perennial Lolium perenne | 351(a) | 1,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 004 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103877 | N/A | Pollens - Grasses, Ryegrass, Perennial Lolium perenne | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 005 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103877 | N/A | Pollens - Grasses, Ryegrass, Perennial Lolium perenne | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 006 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103878 | N/A | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 001 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103878 | N/A | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | 100BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 002 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103878 | N/A | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 003 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103878 | N/A | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | 1,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 004 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103878 | N/A | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 005 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103878 | N/A | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 006 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103879 | N/A | Pollens - Grasses, Timothy Phleum pratense | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 001 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103879 | N/A | Pollens - Grasses, Timothy Phleum pratense | 351(a) | 100BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 002 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103879 | N/A | Pollens - Grasses, Timothy Phleum pratense | 351(a) | 100,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 003 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103879 | N/A | Pollens - Grasses, Timothy Phleum pratense | 351(a) | 1,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 004 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103879 | N/A | Pollens - Grasses, Timothy Phleum pratense | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 005 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103879 | N/A | Pollens - Grasses, Timothy Phleum pratense | 351(a) | 100,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 006 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103880 | N/A | Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia | 351(a) | 1:20W/V | Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 001 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103880 | N/A | Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia | 351(a) | 1:20W/V | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 002 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103880 | N/A | Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia | 351(a) | 1:20W/V | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 003 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103882 | N/A | Venoms, Honey Bee Venom | 351(a) | 100UG/ML | For Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 001 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103882 | N/A | Venoms, Honey Bee Venom | 351(a) | 100UG/ML | For Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 002 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103882 | N/A | Venoms, Honey Bee Venom | 351(a) | 100UG/ML | For Injection | Percutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 003 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103882 | N/A | Venoms, Honey Bee Venom | 351(a) | 100UG/ML | For Injection | Subcutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 004 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103883 | N/A | Venoms, Mixed Vespid Venom Protein | 351(a) | 100UG/ML | For Injection | Subcutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 001 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103883 | N/A | Venoms, Mixed Vespid Venom Protein | 351(a) | 100UG/ML | For Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 002 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103884 | N/A | Venoms, Wasp Venom Protein | 351(a) | 100UG/ML | For Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 001 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103884 | N/A | Venoms, Wasp Venom Protein | 351(a) | 100UG/ML | For Injection | Subcutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 002 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103884 | N/A | Venoms, Wasp Venom Protein | 351(a) | 100UG/ML | For Injection | Percutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 003 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103884 | N/A | Venoms, Wasp Venom Protein | 351(a) | 100UG/ML | For Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 004 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103885 | N/A | Venoms, White Faced Hornet Venom Protein | 351(a) | 100UG/ML | For Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 001 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103885 | N/A | Venoms, White Faced Hornet Venom Protein | 351(a) | 100UG/ML | For Injection | Percutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 002 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103885 | N/A | Venoms, White Faced Hornet Venom Protein | 351(a) | 100UG/ML | For Injection | Subcutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 003 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103885 | N/A | Venoms, White Faced Hornet Venom Protein | 351(a) | 100UG/ML | For Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 004 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103886 | N/A | Venoms, Yellow Hornet Venom Protein | 351(a) | 100UG/ML | For Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 001 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103886 | N/A | Venoms, Yellow Hornet Venom Protein | 351(a) | 100UG/ML | For Injection | Subcutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 002 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103886 | N/A | Venoms, Yellow Hornet Venom Protein | 351(a) | 100UG/ML | For Injection | Percutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 003 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103886 | N/A | Venoms, Yellow Hornet Venom Protein | 351(a) | 100UG/ML | For Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 004 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103887 | N/A | Venoms, Yellow Jacket Venom Protein | 351(a) | 100UG/ML | For Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 001 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103887 | N/A | Venoms, Yellow Jacket Venom Protein | 351(a) | 100UG/ML | For Injection | Subcutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 002 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103887 | N/A | Venoms, Yellow Jacket Venom Protein | 351(a) | 100UG/ML | For Injection | Percutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 003 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103887 | N/A | Venoms, Yellow Jacket Venom Protein | 351(a) | 100UG/ML | For Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 004 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103889 | N/A | Animal Allergens, Standardized Cat Hair | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 001 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103889 | N/A | Animal Allergens, Standardized Cat Hair | 351(a) | 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 002 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103889 | N/A | Animal Allergens, Standardized Cat Hair | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 003 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103890 | N/A | Animal Allergens, Standardized Cat Pelt | 351(a) | 10,000BAU/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 001 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103890 | N/A | Animal Allergens, Standardized Cat Pelt | 351(a) | 10,000BAU/ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 002 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103890 | N/A | Animal Allergens, Standardized Cat Pelt | 351(a) | 10,000BAU/ML | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 003 | CBER | ||||||||||
|
|
Jubilant HollisterStier LLC | 103891 | N/A | Positive Skin Test Control-Histamine | 351(a) | 6MG/ML | Injection | Percutaneous | Dropper Vial | Rx | Licensed | March 13, 1924 | 0 | Original | 1272 | 001 | CBER | ||||||||||
|
|
MD Anderson Cord Blood Bank | 125657 | N/A | Hematopoietic Progenitor Cells, Cord (HPC-C) | 351(a) | 2.5X10E7/KG CELL/ML | Injection | Intravenous | Bag | Rx | Licensed | June 21, 2018 | 0 | Original | 2072 | 001 | CBER | ||||||||||
|
|
Merck Teknika LLC | 103050 | N/A | BCG Vaccine | 351(a) | 100-800 MIL CFU | For Injection | Percutaneous | Single-Dose Vial | Rx | Licensed | June 21, 1989 | 0 | Original | 1747 | 001 | CBER | ||||||||||
|
|
Nielsen Bioscience, Inc | 103317 | N/A | Positive Skin Test Control-Histamine | 351(a) | 1.8MG/ML | Injection | Percutaneous | Vial | Disc | Licensed | February 14, 1992 | 0 | Original | 1903 | 001 | CBER | ||||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125154 | N/A | Albumin (Human) | 351(a) | 12.5G/250ML | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | October 17, 2006 | 0 | Original | 1646 | 001 | CBER | ||||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125154 | N/A | Albumin (Human) | 351(a) | 5G/100ML | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | October 17, 2006 | 0 | Original | 1646 | 002 | CBER | ||||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125154 | N/A | Albumin (Human) | 351(a) | 10G/50ML | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | September 27, 2007 | 17 | Supplement | 1646 | 003 | CBER | ||||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125154 | N/A | Albumin (Human) | 351(a) | 25G/100ML | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | October 17, 2006 | 0 | Original | 1646 | 004 | CBER | ||||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125154 | N/A | Albumin (Human) | 351(a) | 25G/500ML | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | October 17, 2006 | 0 | Original | 1646 | 005 | CBER | ||||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125154 | N/A | Albumin (Human) | 351(a) | 20G/100ML | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | September 27, 2007 | 17 | Supplement | 1646 | 006 | CBER | ||||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125154 | N/A | Albumin (Human) | 351(a) | 12.5G/50ML | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | October 17, 2006 | 0 | Original | 1646 | 007 | CBER | ||||||||||
|
|
Sanofi Pasteur Inc. | 103913 | N/A | Tetanus Toxoid Adsorbed | 351(a) | 5LF/.5ML | Injection | Intramuscular | Vial | Rx | Voluntarily Revoked | December 9, 1999 | 0 | Original | 1725 | 001 | CBER | ||||||||||
|
|
Sanofi Pasteur Inc. | 103919 | N/A | Diphtheria & Tetanus Toxoids Adsorbed | 351(a) | 6.6; 5 UNITS | Injection | Intramuscular | Vial | Rx | Voluntarily Revoked | December 9, 1999 | 0 | Original | 1725 | 001 | CBER | ||||||||||
|
|
Sanofi Pasteur Inc. | 103921 | N/A | Tetanus and Diphtheria Toxoids Adsorbed | 351(a) | 2.5LF, 5LF, 2.5UG, 8UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Voluntarily Revoked | December 9, 1999 | 0 | Original | 1725 | 001 | CBER | ||||||||||
|
|
Sanofi Pasteur Inc. | 103921 | N/A | Tetanus and Diphtheria Toxoids Adsorbed | 351(a) | 2.5LF, 5LF, 2.5UG, 8UG/.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Voluntarily Revoked | December 9, 1999 | 0 | Original | 1725 | 002 | CBER | ||||||||||
|
|
Sanofi Pasteur Inc. | 125244 | N/A | Influenza Virus Vaccine, H5N1 | 351(a) | 90 MG/.5ML | Injection | Intramuscular | Vial | Disc | Licensed | April 17, 2007 | 0 | Original | 1725 | 001 | CBER | ||||||||||
|
|
Sanofi Pasteur Limited | 103944 | N/A | Diphtheria & Tetanus Toxoids Adsorbed | 351(a) | 25/LF/5LF/0.5ML | Injection | Intramuscular | Single-Dose Vial | Disc | Voluntarily Revoked | February 24, 2000 | 0 | Original | 1726 | 001 | CBER | ||||||||||
|
|
Sanofi Pasteur Limited | 103937 | N/A | Botulism Antitoxin Bivalent (Equine) Types A and B. | 351(a) | 5000IU | Injection | Intravenous | Vial | Rx | Voluntarily Revoked | February 24, 2000 | 0 | Original | 1726 | 001 | CBER | ||||||||||
|
|
Teva Women's Health, Inc. | 125296 | N/A | Adenovirus Type 4 and Type 7 Vaccine, Live, Oral | 351(a) | 4.5LOG 10TCID | Tablet | Oral | Bottle | Rx | Licensed | March 16, 2011 | 0 | Original | 1804 | 001 | CBER | ||||||||||
|
|
Wyeth Pharmaceuticals LLC | 101098 | N/A | Antivenin (Crotalidae) Polyvalent | 351(a) | 10ML | For Injection | Intravenous | Vial | Disc | Voluntarily Revoked | February 8, 1954 | 0 | Original | 0003 | 001 | CBER | ||||||||||
|
|
ADMA Biologics, Inc. | 103945 | Nabi-HB | Hepatitis B Immune Globulin (Human) | 351(a) | 312IU/ML | Injection | Intramuscular | Single-Dose Vial | Disc | Licensed | October 23, 2001 | 0 | Original | 2019 | 001 | CBER | ||||||||||
|
|
ADMA Biologics, Inc. | 103945 | Nabi-HB | Hepatitis B Immune Globulin (Human) | 351(a) | 1560IU/5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | October 23, 2001 | 0 | Original | 2019 | 002 | CBER | ||||||||||
|
|
BioMarin Pharmaceutical Inc. | 125117 | Naglazyme | galsulfase | 351(a) | 5MG/5ML (1MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 31, 2005 | Original | 1649 | 001 | CDER | May 31, 2012 | ||||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 125511 | Natpara | parathyroid hormone | 351(a) | 25MCG | For Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | January 23, 2015 | Original | 1898 | 001 | CDER | January 23, 2022 | ||||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 125511 | Natpara | parathyroid hormone | 351(a) | 50MCG | For Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | January 23, 2015 | Original | 1898 | 002 | CDER | January 23, 2022 | ||||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 125511 | Natpara | parathyroid hormone | 351(a) | 75MCG | For Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | January 23, 2015 | Original | 1898 | 003 | CDER | January 23, 2022 | ||||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 125511 | Natpara | parathyroid hormone | 351(a) | 100MCG | For Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | January 23, 2015 | Original | 1898 | 004 | CDER | January 23, 2022 | ||||||||||
|
|
Galderma Laboratories, L.P. | 761390 | Nemluvio | nemolizumab-ilto | 351(a) | 30MG | For Injection | Subcutaneous | Autoinjector | Rx | Licensed | August 12, 2024 | Original | 2289 | 001 | CDER | |||||||||||
|
|
Amgen Inc. | 125031 | Neulasta | pegfilgrastim | 351(a) | 6MG/0.6ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | January 31, 2002 | Original | 1080 | 001 | CDER | November 13, 2022 | Yes | |||||||||
|
|
Amgen Inc. | 125031 | Neulasta Onpro | pegfilgrastim | 351(a) | 6MG/0.6ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | December 23, 2014 | 175 | Supplement | 1080 | 002 | CDER | November 13, 2022 | |||||||||
|
|
Wyeth Pharmaceuticals Inc. | 103694 | Neumega | oprelvekin | 351(a) | 5MG | For Injection | Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | November 25, 1997 | Original | 0003 | 001 | CDER | |||||||||||
|
|
Amgen Inc. | 103353 | Neupogen | filgrastim | 351(a) | 300MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | February 20, 1991 | Original | 1080 | 001 | CDER | March 30, 2022 | ||||||||||
|
|
Amgen Inc. | 103353 | Neupogen | filgrastim | 351(a) | 480MCG/1.6ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | February 20, 1991 | Original | 1080 | 002 | CDER | March 30, 2022 | ||||||||||
|
|
Amgen Inc. | 103353 | Neupogen | filgrastim | 351(a) | 300MCG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | June 28, 2000 | 1043 | Supplement | 1080 | 003 | CDER | March 30, 2022 | |||||||||
|
|
Amgen Inc. | 103353 | Neupogen | filgrastim | 351(a) | 480MCG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | June 28, 2000 | 1043 | Supplement | 1080 | 004 | CDER | March 30, 2022 | |||||||||
|
|
Palatin Technologies, Inc. | 103928 | NeutroSpec | technetium 99m tc fanolesomab | 351(a) | 0.25MG | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | July 2, 2004 | 1588 | 001 | CDER | ||||||||||||
|
|
Vericel Corporation | 761192 | Nexobrid | anacaulase-bcdb | 351(a) | 8.8% (1.94GM) | For Topical Gel | Topical | Single-Use Jar | Disc | Licensed | December 28, 2022 | Original | 2010 | 001 | CDER | August 15, 2031 | ||||||||||
|
|
Vericel Corporation | 761192 | Nexobrid | anacaulase-bcdb | 351(a) | 8.8% (4.85GM) | For Topical Gel | Topical | Single-Use Jar | Rx | Licensed | December 28, 2022 | Original | 2010 | 002 | CDER | August 15, 2031 | ||||||||||
|
|
Genzyme Corporation | 761194 | Nexviazyme | avalglucosidase alfa-ngpt | 351(a) | 100MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 6, 2021 | Original | 1596 | 001 | CDER | |||||||||||
|
|
Pfizer Ireland Pharmaceuticals | 761184 | Ngenla | somatrogon-ghla | 351(a) | 24MG/1.2ML (20MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | June 27, 2023 | Original | 2060 | 001 | CDER | June 27, 2030 | ||||||||||
|
|
Pfizer Ireland Pharmaceuticals | 761184 | Ngenla | somatrogon-ghla | 351(a) | 60MG/1.2ML (50MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | June 27, 2023 | Original | 2060 | 002 | CDER | June 27, 2030 | ||||||||||
|
|
Incyte Corporation | 761411 | Niktimvo | axatilimab-csfr | 351(a) | 50MG/ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 14, 2024 | Original | 2228 | 001 | CDER | August 14, 2031 | ||||||||||
|
|
Hospira Inc., a Pfizer Company | 761080 | Nivestym | filgrastim-aafi | 351(k) Biosimilar | 300MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | July 20, 2018 | filgrastim | Neupogen | Original | 1974 | 001 | CDER | |||||||||
|
|
Hospira Inc., a Pfizer Company | 761080 | Nivestym | filgrastim-aafi | 351(k) Biosimilar | 480MCG/1.6ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | July 20, 2018 | filgrastim | Neupogen | Original | 1974 | 002 | CDER | |||||||||
|
|
Hospira Inc., a Pfizer Company | 761080 | Nivestym | filgrastim-aafi | 351(k) Biosimilar | 300MCG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | July 20, 2018 | filgrastim | Neupogen | Original | 1974 | 003 | CDER | |||||||||
|
|
Hospira Inc., a Pfizer Company | 761080 | Nivestym | filgrastim-aafi | 351(k) Biosimilar | 480MCG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | July 20, 2018 | filgrastim | Neupogen | Original | 1974 | 004 | CDER | |||||||||
|
|
Novo Nordisk Inc. | 021148 | Norditropin | somatropin | 351(a) | 5MG/1.5ML | Injection | Subcutaneous | Multi-Dose Cartridge | Disc | Licensed | June 20, 2000 | Original | 1261 | 001 | CDER | May 31, 2014 | ||||||||||
|
|
Novo Nordisk Inc. | 021148 | Norditropin | somatropin | 351(a) | 10MG/1.5ML | Injection | Subcutaneous | Multi-Dose Cartridge | Disc | Licensed | June 20, 2000 | Original | 1261 | 002 | CDER | May 31, 2014 | ||||||||||
|
|
Novo Nordisk Inc. | 021148 | Norditropin | somatropin | 351(a) | 15MG/1.5ML | Injection | Subcutaneous | Multi-Dose Cartridge | Disc | Licensed | June 20, 2000 | Original | 1261 | 003 | CDER | May 31, 2014 | ||||||||||
|
|
Novo Nordisk Inc. | 021148 | Norditropin | somatropin | 351(a) | 5MG/1.5ML | Injection | Subcutaneous | Autoinjector | Disc | Licensed | October 1, 2004 | 6 | Supplement | 1261 | 004 | CDER | May 31, 2014 | |||||||||
|
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Novo Nordisk Inc. | 021148 | Norditropin | somatropin | 351(a) | 10MG/1.5ML | Injection | Subcutaneous | Autoinjector | Disc | Licensed | October 1, 2004 | 6 | Supplement | 1261 | 005 | CDER | May 31, 2014 | |||||||||
|
|
Novo Nordisk Inc. | 021148 | Norditropin | somatropin | 351(a) | 15MG/1.5ML | Injection | Subcutaneous | Autoinjector | Disc | Licensed | October 1, 2004 | 6 | Supplement | 1261 | 006 | CDER | May 31, 2014 | |||||||||
|
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Novo Nordisk Inc. | 021148 | Norditropin | somatropin | 351(a) | 30MG/3ML | Injection | Subcutaneous | Autoinjector | Disc | Licensed | March 10, 2009 | 25 | Supplement | 1261 | 007 | CDER | May 31, 2014 | |||||||||
|
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Novo Nordisk Inc. | 021148 | Norditropin | somatropin | 351(a) | 5MG/1.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | March 1, 2010 | 27 | Supplement | 1261 | 008 | CDER | May 31, 2014 | |||||||||
|
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Novo Nordisk Inc. | 021148 | Norditropin | somatropin | 351(a) | 10MG/1.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | March 1, 2010 | 27 | Supplement | 1261 | 009 | CDER | May 31, 2014 | |||||||||
|
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Novo Nordisk Inc. | 021148 | Norditropin | somatropin | 351(a) | 15MG/1.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | March 1, 2010 | 27 | Supplement | 1261 | 010 | CDER | May 31, 2014 | |||||||||
|
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Novo Nordisk Inc. | 021148 | Norditropin | somatropin | 351(a) | 30MG/3ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | January 23, 2015 | 42 | Supplement | 1261 | 011 | CDER | May 31, 2014 | |||||||||
|
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Ferring Pharmaceuticals Inc. | 017016 | Novarel | chorionic gonadotropin | 351(a) | 20,000UNITS | For Injection | Intramuscular | Multi-Dose Vial | Disc | Licensed | January 15, 1974 | Original | 2112 | 004 | CDER | |||||||||||
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Ferring Pharmaceuticals Inc. | 017016 | Novarel | chorionic gonadotropin | 351(a) | 5,000UNITS | For Injection | Intramuscular | Multi-Dose Vial | Rx | Licensed | January 15, 1974 | Original | 2112 | 006 | CDER | |||||||||||
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Ferring Pharmaceuticals Inc. | 017016 | Novarel | chorionic gonadotropin | 351(a) | 10,000UNITS | For Injection | Intramuscular | Multi-Dose Vial | Disc | Licensed | January 15, 1974 | Original | 2112 | 007 | CDER | |||||||||||
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Ferring Pharmaceuticals Inc. | 017016 | Novarel | chorionic gonadotropin | 351(a) | 2,000UNITS | For Injection | Intramuscular | Multi-Dose Vial | Disc | Licensed | December 27, 1984 | 132 | Supplement | 2112 | 009 | CDER | ||||||||||
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Ferring Pharmaceuticals Inc. | 017016 | Novarel | chorionic gonadotropin | 351(a) | 15,000UNITS | For Injection | Intramuscular | Multi-Dose Vial | Disc | Licensed | February 15, 1985 | 131 | Supplement | 2112 | 010 | CDER | ||||||||||
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Ferring Pharmaceuticals Inc. | 017016 | Novarel | chorionic gonadotropin | 351(a) | 2,000UNITS | For Injection | Intramuscular | Multi-Dose Vial | Disc | Licensed | February 16, 1990 | 136 | Supplement | 2112 | 011 | CDER | ||||||||||
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Novo Nordisk Inc. | 125466 | Novoeight | Antihemophilic Factor (Recombinant) | 351(a) | 3000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 15, 2013 | 0 | Original | 1261 | 001 | CBER | ||||||||||
|
|
Novo Nordisk Inc. | 125466 | Novoeight | Antihemophilic Factor (Recombinant) | 351(a) | 2000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 15, 2013 | 0 | Original | 1261 | 002 | CBER | ||||||||||
|
|
Novo Nordisk Inc. | 125466 | Novoeight | Antihemophilic Factor (Recombinant) | 351(a) | 1500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 15, 2013 | 0 | Original | 1261 | 003 | CBER | ||||||||||
|
|
Novo Nordisk Inc. | 125466 | Novoeight | Antihemophilic Factor (Recombinant) | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 15, 2013 | 0 | Original | 1261 | 004 | CBER | ||||||||||
|
|
Novo Nordisk Inc. | 125466 | Novoeight | Antihemophilic Factor (Recombinant) | 351(a) | 250IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 15, 2013 | 0 | Original | 1261 | 005 | CBER | ||||||||||
|
|
Novo Nordisk Inc. | 125466 | Novoeight | Antihemophilic Factor (Recombinant) | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 15, 2013 | 0 | Original | 1261 | 006 | CBER | ||||||||||
|
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Novo Nordisk Inc. | 019991 | Novolin 70/30 | insulin isophane human and insulin human | 351(a) | 300UNITS/10ML (30UNITS/ML); 700UNITS/10ML (70UNITS/ML) | Injection | Subcutaneous | Multi-Dose Vial | OTC | Licensed | June 25, 1991 | Original | 1261 | 001 | CDER | |||||||||||
|
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Novo Nordisk Inc. | 019991 | Novolin 70/30 | insulin isophane human and insulin human | 351(a) | 90UNITS/3ML (30UNITS/ML); 210UNITS/3ML (70UNITS/ML) | Injection | Subcutaneous | Autoinjector | OTC | Licensed | June 1, 2018 | 79 | Supplement | 1261 | 002 | CDER | ||||||||||
|
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Novo Nordisk Inc. | 019959 | Novolin N | insulin isophane human | 351(a) | 1,000UNITS/10ML (100UNITS/ML) | Injectable Suspension | Subcutaneous | Multi-Dose Vial | OTC | Licensed | July 1, 1991 | Original | 1261 | 001 | CDER | |||||||||||
|
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Novo Nordisk Inc. | 019959 | Novolin N | insulin isophane human | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injectable Suspension | Subcutaneous | Autoinjector | OTC | Licensed | July 1, 1991 | Original | 1261 | 002 | CDER | |||||||||||
|
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Novo Nordisk Inc. | 019938 | Novolin R | insulin human | 351(a) | 1,000UNITS/10ML (100UNITS/ML) | Injection | Subcutaneous | Multi-Dose Vial | OTC | Licensed | June 25, 1991 | Original | 1261 | 001 | CDER | |||||||||||
|
|
Novo Nordisk Inc. | 019938 | Novolin R | insulin human | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | OTC | Licensed | June 1, 2018 | 76 | Supplement | 1261 | 002 | CDER | ||||||||||
|
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Novo Nordisk Inc. | 020986 | Novolog | insulin aspart | 351(a) | 1,000UNITS/10ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 7, 2000 | Original | 1261 | 001 | CDER | |||||||||||
|
|
Novo Nordisk Inc. | 020986 | Novolog | insulin aspart | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Multi-Dose Cartridge | Rx | Licensed | June 7, 2000 | Original | 1261 | 002 | CDER | |||||||||||
|
|
Novo Nordisk Inc. | 020986 | Novolog | insulin aspart | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | January 19, 2001 | 1 | Supplement | 1261 | 003 | CDER | ||||||||||
|
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Novo Nordisk Inc. | 020986 | Novolog | insulin aspart | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Disc | Licensed | April 23, 2004 | 23 | Supplement | 1261 | 004 | CDER | ||||||||||
|
|
Novo Nordisk Inc. | 020986 | Novolog | insulin aspart | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Disc | Licensed | October 31, 2013 | 61 | Supplement | 1261 | 005 | CDER | ||||||||||
|
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Novo Nordisk Inc. | 021810 | Novolog Mix 50/50 | insulin aspart protamine and insulin aspart | 351(a) | 150UNITS/3ML (50UNITS/ML); 150UNITS/3ML (50UNITS/ML) | Injectable Suspension | Subcutaneous | Multi-Dose Cartridge | Disc | Voluntarily Revoked | August 26, 2008 | Original | 1261 | 001 | CDER | |||||||||||
|
|
Novo Nordisk Inc. | 021810 | Novolog Mix 50/50 | insulin aspart protamine and insulin aspart | 351(a) | 150UNITS/3ML (50UNITS/ML); 150UNITS/3ML (50UNITS/ML) | Injectable Suspension | Subcutaneous | Autoinjector | Disc | Voluntarily Revoked | August 26, 2008 | Original | 1261 | 002 | CDER | |||||||||||
|
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Novo Nordisk Inc. | 021172 | Novolog Mix 70/30 | insulin aspart protamine and insulin aspart | 351(a) | 700UNITS/10ML (70UNITS/ML); 300UNITS/10ML (30UNITS/ML) | Injectable Suspension | Subcutaneous | Multi-Dose Vial | Rx | Licensed | November 1, 2001 | Original | 1261 | 001 | CDER | |||||||||||
|
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Novo Nordisk Inc. | 021172 | Novolog Mix 70/30 | insulin aspart protamine and insulin aspart | 351(a) | 210UNITS/3ML (70UNITS/ML); 90UNITS/3ML (30UNITS/ML) | Injectable Suspension | Subcutaneous | Autoinjector | Disc | Licensed | November 1, 2001 | Original | 1261 | 002 | CDER | |||||||||||
|
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Novo Nordisk Inc. | 021172 | Novolog Mix 70/30 | insulin aspart protamine and insulin aspart | 351(a) | 210UNITS/3ML (70UNITS/ML); 90UNITS/3ML (30UNITS/ML) | Injectable Suspension | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | November 1, 2001 | Original | 1261 | 003 | CDER | |||||||||||
|
|
Novo Nordisk Inc. | 021172 | Novolog Mix 70/30 | insulin aspart protamine and insulin aspart | 351(a) | 210UNITS/3ML (70UNITS/ML); 90UNITS/3ML (30UNITS/ML) | Injectable Suspension | Subcutaneous | Autoinjector | Rx | Licensed | May 3, 2002 | 1 | Supplement | 1261 | 004 | CDER | ||||||||||
|
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Novo Nordisk Inc. | 103665 | Novoseven, Novoseven Rt | Coagulation Factor VIIa (Recombinant) | 351(a) | 2.4MG | For Injection | Intravenous | Single-Dose Vial | Disc | Licensed | March 25, 1999 | 0 | Original | 1261 | 001 | CBER | July 2, 2021 | |||||||||
|
|
Novo Nordisk Inc. | 103665 | Novoseven, Novoseven Rt | Coagulation Factor VIIa (Recombinant) | 351(a) | 1.2MG | For Injection | Intravenous | Vial | Disc | Licensed | November 15, 2000 | 5000 | Supplement | 1261 | 002 | CBER | July 2, 2021 | |||||||||
|
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Novo Nordisk Inc. | 103665 | Novoseven, Novoseven Rt | Coagulation Factor VIIa (Recombinant) | 351(a) | 4.8MG | For Injection | Intravenous | Vial | Disc | Licensed | November 15, 2000 | 5000 | Supplement | 1261 | 003 | CBER | July 2, 2021 | |||||||||
|
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Novo Nordisk Inc. | 103665 | Novoseven, Novoseven Rt | Coagulation Factor VIIa (Recombinant) | 351(a) | 5.0MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 9, 2008 | 5231 | Supplement | 1261 | 004 | CBER | July 2, 2021 | |||||||||
|
|
Novo Nordisk Inc. | 103665 | Novoseven, Novoseven Rt | Coagulation Factor VIIa (Recombinant) | 351(a) | 1.0MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 9, 2008 | 5231 | Supplement | 1261 | 005 | CBER | July 2, 2021 | |||||||||
|
|
Novo Nordisk Inc. | 103665 | Novoseven, Novoseven Rt | Coagulation Factor VIIa (Recombinant) | 351(a) | 2.0MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 9, 2008 | 5231 | Supplement | 1261 | 006 | CBER | July 2, 2021 | |||||||||
|
|
Novo Nordisk Inc. | 103665 | Novoseven, Novoseven Rt | Coagulation Factor VIIa (Recombinant) | 351(a) | 8.0MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 6, 2010 | 5605 | Supplement | 1261 | 007 | CBER | July 2, 2021 | |||||||||
|
|
Amgen Inc. | 125268 | Nplate | romiplostim | 351(a) | 250MCG | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | August 22, 2008 | Original | 1080 | 001 | CDER | January 28, 2028 | ||||||||||
|
|
Amgen Inc. | 125268 | Nplate | romiplostim | 351(a) | 500MCG | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | August 22, 2008 | Original | 1080 | 002 | CDER | January 28, 2028 | ||||||||||
|
|
Amgen Inc. | 125268 | Nplate | romiplostim | 351(a) | 125MCG | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | July 22, 2019 | 165 | Supplement | 1080 | 003 | CDER | January 28, 2028 | |||||||||
|
|
GlaxoSmithKline LLC | 125526 | Nucala | mepolizumab | 351(a) | 100MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | November 4, 2015 | Original | 1727 | 001 | CDER | September 25, 2027 | ||||||||||
|
|
GlaxoSmithKline LLC | 125526 | Nucala | mepolizumab | 351(a) | 100MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | June 6, 2019 | 13 | Supplement | 1727 | 002 | CDER | September 25, 2027 | |||||||||
|
|
GlaxoSmithKline LLC | 125526 | Nucala | mepolizumab | 351(a) | 100MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | June 6, 2019 | 13 | Supplement | 1727 | 003 | CDER | September 25, 2027 | |||||||||
|
|
GlaxoSmithKline LLC | 761122 | Nucala | mepolizumab | 351(a) | 100MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | June 6, 2019 | Original | 1727 | 001 | CDER | |||||||||||
|
|
GlaxoSmithKline LLC | 761122 | Nucala | mepolizumab | 351(a) | 100MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | June 6, 2019 | Original | 1727 | 002 | CDER | |||||||||||
|
|
GlaxoSmithKline LLC | 761122 | Nucala | mepolizumab | 351(a) | 100MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | June 6, 2019 | Original | 1727 | 003 | CDER | |||||||||||
|
|
GlaxoSmithKline LLC | 125526 | Nucala | mepolizumab | 351(a) | 40MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | January 22, 2022 | 19 | Supplement | 1727 | 004 | CDER | ||||||||||
|
|
GlaxoSmithKline LLC | 761122 | Nucala | mepolizumab | 351(a) | 40MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | January 22, 2022 | 8 | Supplement | 1727 | 004 | CDER | ||||||||||
|
|
Formycon AG | 761473 | Nufymco | ranibizumab-leyk | 351(k) Interchangeable | 10MG/ML (0.5MG/0.05ML) | Injection | Intravitreal | Single-Dose Vial | Rx | Licensed | December 18, 2025 | December 18, 2025 | ranibizumab | Lucentis | Original | 2322 | 001 | CDER | ||||||||
|
|
Formycon AG | 761473 | Nufymco | ranibizumab-leyk | 351(k) Interchangeable | 6MG/ML (0.3MG/0.05ML) | Injection | Intravitreal | Single-Dose Vial | Rx | Licensed | December 18, 2025 | December 18, 2025 | ranibizumab | Lucentis | Original | 2322 | 002 | CDER | ||||||||
|
|
Bristol-Myers Squibb Company | 125288 | Nulojix | belatacept | 351(a) | 250MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 15, 2011 | Original | 1713 | 001 | CDER | June 15, 2018 | ||||||||||
|
|
Genentech, Inc. | 020168 | Nutropin | somatropin | 351(a) | 5MG | For Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | November 17, 1993 | Original | 1048 | 001 | CDER | December 30, 2003 | ||||||||||
|
|
Genentech, Inc. | 020168 | Nutropin | somatropin | 351(a) | 10MG | For Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | November 17, 1993 | Original | 1048 | 002 | CDER | December 30, 2003 | ||||||||||
|
|
Genentech, Inc. | 020522 | Nutropin AQ | somatropin | 351(a) | 10MG/2ML | Injection | Subcutaneous | Vial | Disc | Voluntarily Revoked | December 29, 1995 | Original | 1048 | 001 | CDER | |||||||||||
|
|
Genentech, Inc. | 020522 | Nutropin AQ | somatropin | 351(a) | 10MG/2ML | Injection | Subcutaneous | Multi-Dose Cartridge | Disc | Voluntarily Revoked | April 22, 2002 | 17 | Supplement | 1048 | 002 | CDER | ||||||||||
|
|
Genentech, Inc. | 020522 | Nutropin AQ | somatropin | 351(a) | 5MG/2ML | Injection | Subcutaneous | Autoinjector | Disc | Voluntarily Revoked | January 3, 2008 | 37 | Supplement | 1048 | 003 | CDER | ||||||||||
|
|
Genentech, Inc. | 020522 | Nutropin AQ | somatropin | 351(a) | 20MG/2ML | Injection | Subcutaneous | Autoinjector | Disc | Voluntarily Revoked | January 3, 2008 | 37 | Supplement | 1048 | 004 | CDER | ||||||||||
|
|
Genentech, Inc. | 020522 | Nutropin AQ | somatropin | 351(a) | 10MG/2ML | Injection | Subcutaneous | Autoinjector | Disc | Voluntarily Revoked | January 3, 2008 | 36 | Supplement | 1048 | 005 | CDER | ||||||||||
|
|
Genentech, Inc. | 020522 | Nutropin AQ | somatropin | 351(a) | 20MG/2ML | Injection | Subcutaneous | Multi-Dose Cartridge | Disc | Voluntarily Revoked | January 3, 2008 | 26 | Supplement | 1048 | 006 | CDER | ||||||||||
|
|
Novavax, Inc. | 125817 | NUVAXOVID | COVID-19 Vaccine, Adjuvanted | 351(a) | 5UG | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | May 16, 2025 | 0 | Original | 2349 | 001 | CBER | ||||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125555 | Nuwiq | Antihemophilic Factor (Recombinant) | 351(a) | 500IU | For Injection | Intravenous | Vial | Rx | Licensed | September 4, 2015 | 0 | Original | 1646 | 001 | CBER | ||||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125555 | Nuwiq | Antihemophilic Factor (Recombinant) | 351(a) | 1000IU | For Injection | Intravenous | Vial | Rx | Licensed | September 4, 2015 | 0 | Original | 1646 | 002 | CBER | ||||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125555 | Nuwiq | Antihemophilic Factor (Recombinant) | 351(a) | 250IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | September 4, 2015 | 0 | Original | 1646 | 003 | CBER | ||||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125555 | Nuwiq | Antihemophilic Factor (Recombinant) | 351(a) | 2000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | September 4, 2015 | 0 | Original | 1646 | 004 | CBER | ||||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125555 | Nuwiq | Antihemophilic Factor (Recombinant) | 351(a) | 2500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 7, 2017 | 55 | Supplement | 1646 | 005 | CBER | ||||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125555 | Nuwiq | Antihemophilic Factor (Recombinant) | 351(a) | 4000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 7, 2017 | 55 | Supplement | 1646 | 006 | CBER | ||||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125555 | Nuwiq | Antihemophilic Factor (Recombinant) | 351(a) | 3000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 7, 2017 | 55 | Supplement | 1646 | 007 | CBER | ||||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125555 | Nuwiq | Antihemophilic Factor (Recombinant) | 351(a) | 1500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 7, 2021 | 245 | Supplement | 1646 | 008 | CBER | ||||||||||
|
|
Tanvex BioPharma USA, Inc. | 761126 | Nypozi | filgrastim-txid | 351(k) Biosimilar | 300MCG/0.5ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | June 28, 2024 | filgrastim | Neupogen | Original | 2259 | 001 | CDER | |||||||||
|
|
Tanvex BioPharma USA, Inc. | 761126 | Nypozi | filgrastim-txid | 351(k) Biosimilar | 480MCG/0.8ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | June 28, 2024 | filgrastim | Neupogen | Original | 2259 | 002 | CDER | |||||||||
|
|
Hospira Inc., a Pfizer Company | 761111 | Nyvepria | pegfilgrastim-apgf | 351(k) Biosimilar | 6MG/0.6ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | June 10, 2020 | pegfilgrastim | Neulasta | Original | 1974 | 001 | CDER | |||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 125512 | Obizur | Antihemophilic Factor (Recombinant), Porcine Sequence | 351(a) | 500U | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 23, 2014 | 0 | Original | 1898 | 001 | CBER | October 23, 2021 | |||||||||
|
|
Genentech, Inc. | 761053 | Ocrevus | ocrelizumab | 351(a) | 300MG/10ML (30MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 28, 2017 | Original | 1048 | 001 | CDER | |||||||||||
|
|
Genentech, Inc. | 761371 | Ocrevus Zunovo | ocrelizumab and hyaluronidase-ocsq | 351(a) | 920MG/23ML; 23,000UNITS/23ML (40MG/1,000UNITS/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | September 13, 2024 | Original | 1048 | 001 | CDER | |||||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125062 | Octagam | Immune Globulin Intravenous (Human) | 351(a) | 5% 5.0G | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | May 21, 2004 | 0 | Original | 1646 | 001 | CBER | July 15, 2028 | |||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125062 | Octagam | Immune Globulin Intravenous (Human) | 351(a) | 5% 1.0G | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | May 21, 2004 | 0 | Original | 1646 | 002 | CBER | July 15, 2028 | |||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125062 | Octagam | Immune Globulin Intravenous (Human) | 351(a) | 5% 10G | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | May 21, 2004 | 0 | Original | 1646 | 003 | CBER | July 15, 2028 | |||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125062 | Octagam | Immune Globulin Intravenous (Human) | 351(a) | 5% 2.5G | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | May 21, 2004 | 0 | Original | 1646 | 004 | CBER | July 15, 2028 | |||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125062 | Octagam | Immune Globulin Intravenous (Human) | 351(a) | 5% 25G | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | March 26, 2007 | 124 | Supplement | 1646 | 005 | CBER | July 15, 2028 | |||||||||
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125062 | Octagam | Immune Globulin Intravenous (Human) | 351(a) | 10% 20G | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | July 11, 2014 | 234 | Supplement | 1646 | 006 | CBER | July 15, 2028 | |||||||||
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Octapharma Pharmazeutika Produktionsges.m.b.H. | 125062 | Octagam | Immune Globulin Intravenous (Human) | 351(a) | 10% 5G | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | July 11, 2014 | 234 | Supplement | 1646 | 007 | CBER | July 15, 2028 | |||||||||
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Octapharma Pharmazeutika Produktionsges.m.b.H. | 125062 | Octagam | Immune Globulin Intravenous (Human) | 351(a) | 10% 2G | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | July 11, 2014 | 234 | Supplement | 1646 | 008 | CBER | July 15, 2028 | |||||||||
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Octapharma Pharmazeutika Produktionsges.m.b.H. | 125062 | Octagam | Immune Globulin Intravenous (Human) | 351(a) | 10% 10G | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | July 11, 2014 | 234 | Supplement | 1646 | 009 | CBER | July 15, 2028 | |||||||||
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Octapharma Pharmazeutika Produktionsges.m.b.H. | 125416 | Octaplas | Pooled Plasma (Human), Solvent/Detergent Treated | 351(a) | 45-70MG/ML | For Injection | Intravenous | Bag | Rx | Licensed | January 17, 2013 | 0 | Original | 1646 | 001 | CBER | ||||||||||
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ALK - Abello A/S | 125592 | Odactra | House Dust Mites (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract | 351(a) | 12 SQ-HDM/ML | Tablet | Sublingual | Blister Pack | Rx | Licensed | March 1, 2017 | 0 | Original | 1292 | 001 | CBER | ||||||||||
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Biocon Biologics Inc. | 761074 | Ogivri | trastuzumab-dkst | 351(k) Biosimilar | 420MG | For Injection | Intravenous | Multi-Dose Vial | Rx | Licensed | December 1, 2017 | trastuzumab | Herceptin | Original | 2324 | 001 | CDER | |||||||||
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Biocon Biologics Inc. | 761074 | Ogivri | trastuzumab-dkst | 351(k) Biosimilar | 150MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 17, 2019 | trastuzumab | Herceptin | 4 | Supplement | 2324 | 002 | CDER | ||||||||
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Gamida Cell Ltd. | 125738 | OMISIRGE | omidubicel-onlv | 351(a) | >4.0x10^8 total viable cells, >2.4x10^7 CD3+ cells with 41mL dil sol; >8.0x10^8 total viable cells, >8.7% CD34+ cells, >9.2x10^7 CD34+ cells with 81mL dil so | For Injection | Intravenous | Bag | Rx | Licensed | April 17, 2023 | 0 | Original | 2223 | 001 | CBER | April 17, 2030 | |||||||||
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CELLTRION, Inc. | 761399 | Omlyclo | omalizumab-igec | 351(k) Interchangeable | 150MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | March 7, 2025 | March 7, 2025 | omalizumab | Xolair | Original | 1996 | 002 | CDER | Date TBD | |||||||
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CELLTRION, Inc. | 761399 | Omlyclo | omalizumab-igec | 351(k) Interchangeable | 300MG/2ML (150MG/ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | December 1, 2025 | December 1, 2025 | omalizumab | Xolair | Supplement | 4 | 1996 | 003 | CDER | Date TBD | ||||||
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CELLTRION, Inc. | 761399 | Omlyclo | omalizumab-igec | 351(k) Interchangeable | 75MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | March 7, 2025 | March 7, 2025 | omalizumab | Xolair | Original | 1996 | 001 | CDER | Date TBD | |||||||
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Sandoz Inc. | 021426 | Omnitrope | somatropin | 351(a) | 5.8MG | For Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | May 30, 2006 | Original | 2003 | 001 | CDER | |||||||||||
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Sandoz Inc. | 021426 | Omnitrope | somatropin | 351(a) | 1.5MG | For Injection | Subcutaneous | Single-Dose Vial | Disc | Licensed | May 30, 2006 | Original | 2003 | 002 | CDER | |||||||||||
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Sandoz Inc. | 021426 | Omnitrope | somatropin | 351(a) | 5MG/1.5ML | Injection | Subcutaneous | Multi-Dose Cartridge | Rx | Licensed | January 16, 2008 | 2 | Supplement | 2003 | 003 | CDER | ||||||||||
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Sandoz Inc. | 021426 | Omnitrope | somatropin | 351(a) | 10MG/1.5ML | Injection | Subcutaneous | Multi-Dose Cartridge | Rx | Licensed | August 25, 2008 | 4 | Supplement | 2003 | 004 | CDER | ||||||||||
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Eli Lilly and Company | 761279 | Omvoh | mirikizumab-mrkz | 351(a) | 300MG/15ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 26, 2023 | Original | 1891 | 001 | CDER | |||||||||||
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Eli Lilly and Company | 761279 | Omvoh | mirikizumab-mrkz | 351(a) | 100MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | October 26, 2023 | Original | 1891 | 002 | CDER | |||||||||||
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Eli Lilly and Company | 761279 | Omvoh | mirikizumab-mrkz | 351(a) | 100MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | January 15, 2025 | 2 | Supplement | 1891 | 003 | CDER | ||||||||||
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Eli Lilly and Company | 761279 | Omvoh | mirikizumab-mrkz | 351(a) | 200MG/2ML (100MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | January 15, 2025 | 2 | Supplement | 1891 | 004 | CDER | ||||||||||
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Eli Lilly and Company | 761279 | Omvoh | mirikizumab-mrkz | 351(a) | 200MG/2ML (100MG/ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | January 15, 2025 | 2 | Supplement | 1891 | 005 | CDER | ||||||||||
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Servier Pharmaceuticals LLC | 103411 | Oncaspar | pegaspargase | 351(a) | 3,750IU/5ML(750IU/ML) | Injection | Intravenous, Intramuscular | Single-Dose Vial | Rx | Licensed | February 1, 1994 | Original | 2125 | 001 | CDER | February 1, 2001 | ||||||||||
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Eisai, Incorporated | 103767 | Ontak | denileukin diftitox | 351(a) | 150MCG/ML (300MCG/2ML) | Injection | Intravenous | Single-Dose Vial | Disc | Licensed | February 5, 1999 | Original | 1862 | 001 | CDER | February 5, 2006 | ||||||||||
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Samsung Bioepis Co., Ltd. | 761100 | Ontruzant | trastuzumab-dttb | 351(k) Biosimilar | 150MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | January 18, 2019 | trastuzumab | Herceptin | Original | 2046 | 001 | CDER | |||||||||
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Samsung Bioepis Co., Ltd. | 761100 | Ontruzant | trastuzumab-dttb | 351(k) Biosimilar | 420MG | For Injection | Intravenous | Multi-Dose Vial | Rx | Licensed | March 20, 2020 | trastuzumab | Herceptin | 5 | Supplement | 2046 | 002 | CDER | ||||||||
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Bristol-Myers Squibb Company | 125554 | Opdivo | nivolumab | 351(a) | 40MG/4ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 22, 2014 | Original | 1713 | 001 | CDER | April 13, 2031 | ||||||||||
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Bristol-Myers Squibb Company | 125554 | Opdivo | nivolumab | 351(a) | 100MG/10ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 22, 2014 | Original | 1713 | 002 | CDER | April 13, 2031 | ||||||||||
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Bristol-Myers Squibb Company | 125554 | Opdivo | nivolumab | 351(a) | 240MG/24ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 4, 2017 | 43 | Supplement | 1713 | 003 | CDER | April 13, 2031 | |||||||||
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Bristol-Myers Squibb Company | 125554 | Opdivo | nivolumab | 351(a) | 120MG/12ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 27, 2021 | 103 | Supplement | 1713 | 004 | CDER | April 13, 2031 | |||||||||
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Bristol-Myers Squibb Company | 761381 | Opdivo Qvantig | nivolumab and hyaluronidase-nvhy | 351(a) | 600MG/5ML;10,000UNITS/5ML (120MG/2,000UNITS/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | December 27, 2024 | Original | 1713 | 001 | CDER | |||||||||||
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Bristol-Myers Squibb Company | 761381 | Opdivo Qvantig | nivolumab and hyaluronidase-nvhy | 351(a) | 300MG/2.5ML;5,000UNITS/2.5ML (120MG/2,000UNITS/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | November 24, 2025 | 5 | Supplement | 1713 | 002 | CDER | ||||||||||
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Bristol-Myers Squibb Company | 761234 | Opdualag | nivolumab and relatlimab-rmbw | 351(a) | 240MG, 80MG/20ML (12MG, 4MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 18, 2022 | Original | 1713 | 001 | CDER | March 18, 2029 | ||||||||||
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Samsung Bioepis Co., Ltd. | 761350 | Opuviz | aflibercept-yszy | 351(k) Interchangeable | 2MG/0.05ML | Injection | Intravitreal | Single-Dose Vial | Rx | Licensed | May 20, 2024 | May 20, 2024 | aflibercept | Eylea | Original | 2046 | 001 | CDER | Date TBD | |||||||
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Stallergenes, SAS | 125471 | Oralair | Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract | 351(a) | 300 IR TABS/CT | Tablet | Sublingual | Blister Pack | Rx | Licensed | April 1, 2014 | 0 | Original | 1893 | 001 | CBER | ||||||||||
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Bristol-Myers Squibb Company | 125118 | Orencia | abatacept | 351(a) | 250MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 23, 2005 | Original | 1713 | 001 | CDER | December 15, 2028 | ||||||||||
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Bristol-Myers Squibb Company | 125118 | Orencia | abatacept | 351(a) | 125MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | July 29, 2011 | 122 | Supplement | 1713 | 002 | CDER | December 15, 2028 | |||||||||
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Bristol-Myers Squibb Company | 125118 | Orencia | abatacept | 351(a) | 125MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | June 7, 2016 | 200 | Supplement | 1713 | 003 | CDER | December 15, 2028 | |||||||||
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Bristol-Myers Squibb Company | 125118 | Orencia | abatacept | 351(a) | 50MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | March 30, 2017 | 211 | Supplement | 1713 | 004 | CDER | December 15, 2028 | |||||||||
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Bristol-Myers Squibb Company | 125118 | Orencia | abatacept | 351(a) | 87.5MG/0.7ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | March 30, 2017 | 211 | Supplement | 1713 | 005 | CDER | December 15, 2028 | |||||||||
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Centocor Ortho Biotech Products, L.P. | 103463 | Orthoclone OKT3 | muromonab-CD3 | 351(a) | 1MG/ML | Injection | Intravenous | Ampule | Disc | Voluntarily Revoked | September 14, 1992 | 1824 | 001 | CDER | ||||||||||||
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CELLTRION, Inc. | 761404 | Osenvelt | denosumab-bmwo | 351(k) Interchangeable | 120MG/1.7ML (70MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | February 28, 2025 | October 29, 2025 | denosumab | Xgeva | Original | 1996 | 002 | CDER | ||||||||
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Samsung Bioepis Co., Ltd. | 761392 | Ospomyv | denosumab-dssb | 351(k) Interchangeable | 60MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | February 13, 2025 | October 29, 2025 | denosumab | Prolia | Original | 2046 | 001 | CDER | ||||||||
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Accord BioPharma Inc. | 761424 | Osvyrti | denosumab-desu | 351(k) Interchangeable | 60MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | October 29, 2025 | October 29, 2025 | denosumab | Prolia | Original | 2105 | 001 | CDER | ||||||||
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Fresenius Kabi USA, LLC | 761379 | Otulfi | ustekinumab-aauz | 351(k) Interchangeable | 45MG/0.5ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | March 21, 2025 | April 30, 2025 | ustekinumab | Stelara | 2 | Supplement | 4 | 2146 | 004 | CDER | ||||||
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Fresenius Kabi USA, LLC | 761379 | Otulfi | ustekinumab-aauz | 351(k) Interchangeable | 45MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | September 27, 2024 | April 30, 2025 | ustekinumab | Stelara | Original | 2146 | 001 | CDER | ||||||||
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Fresenius Kabi USA, LLC | 761379 | Otulfi | ustekinumab-aauz | 351(k) Interchangeable | 90MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | September 27, 2024 | April 30, 2025 | ustekinumab | Stelara | Original | 2146 | 002 | CDER | ||||||||
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Fresenius Kabi USA, LLC | 761379 | Otulfi | ustekinumab-aauz | 351(k) Interchangeable | 130MG/26ML (5MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | September 27, 2024 | April 30, 2025 | ustekinumab | Stelara | Original | 2146 | 003 | CDER | ||||||||
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EMD Serono, Inc. | 021149 | Ovidrel | choriogonadotropin alfa | 351(a) | 250MCG | Injection | Subcutaneous | Single-Dose Vial | Disc | Licensed | September 20, 2000 | Original | 1773 | 001 | CDER | |||||||||||
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EMD Serono, Inc. | 021149 | Ovidrel | choriogonadotropin alfa | 351(a) | 250MCG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | July 14, 2003 | 6 | Supplement | 1773 | 002 | CDER | ||||||||||
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Dompé farmaceutici S.p.A. | 761094 | Oxervate | cenegermin-bkbj | 351(a) | 0.002% (20MCG/ML) | Solution | Topical | Multi-Dose Vial | Rx | Licensed | August 22, 2018 | Original | 2074 | 001 | CDER | August 22, 2025 | ||||||||||
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Amneal Pharmaceuticals LLC | 761457 | Oziltus | denosumab-mobz | 351(k) Interchangeable | 120MG/1.7ML (70MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | December 19, 2025 | December 19, 2025 | denosumab | Xgeva | Original | 2241 | 001 | CDER | ||||||||
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Astellas Pharma US, Inc. | 761137 | Padcev | enfortumab vedotin-ejfv | 351(a) | 20MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 18, 2019 | Original | 2124 | 001 | CDER | |||||||||||
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Astellas Pharma US, Inc. | 761137 | Padcev | enfortumab vedotin-ejfv | 351(a) | 30MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 18, 2019 | Original | 2124 | 002 | CDER | |||||||||||
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Greer Laboratories, Inc. | 125696 | Palforzia | Peanut (Arachis hypogaea) Allergen Powder-dnfp | 351(a) | 0.5MG | Powder | Oral | Capsule | Rx | Licensed | January 31, 2020 | 0 | Original | 0308 | 001 | CBER | ||||||||||
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Greer Laboratories, Inc. | 125696 | Palforzia | Peanut (Arachis hypogaea) Allergen Powder-dnfp | 351(a) | 1MG | Powder | Oral | Capsule | Rx | Licensed | January 31, 2020 | 0 | Original | 0308 | 002 | CBER | ||||||||||
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Greer Laboratories, Inc. | 125696 | Palforzia | Peanut (Arachis hypogaea) Allergen Powder-dnfp | 351(a) | 10MG | Powder | Oral | Capsule | Rx | Licensed | January 31, 2020 | 0 | Original | 0308 | 003 | CBER | ||||||||||
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Greer Laboratories, Inc. | 125696 | Palforzia | Peanut (Arachis hypogaea) Allergen Powder-dnfp | 351(a) | 20MG | Powder | Oral | Capsule | Rx | Licensed | January 31, 2020 | 0 | Original | 0308 | 004 | CBER | ||||||||||
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Greer Laboratories, Inc. | 125696 | Palforzia | Peanut (Arachis hypogaea) Allergen Powder-dnfp | 351(a) | 100MG | Powder | Oral | Capsule | Rx | Licensed | January 31, 2020 | 0 | Original | 0308 | 005 | CBER | ||||||||||
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Greer Laboratories, Inc. | 125696 | Palforzia | Peanut (Arachis hypogaea) Allergen Powder-dnfp | 351(a) | 300MG | Powder | Oral | Sachet | Rx | Licensed | January 31, 2020 | 0 | Original | 0308 | 006 | CBER | ||||||||||
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BioMarin Pharmaceutical Inc. | 761079 | Palynziq | pegvaliase-pqpz | 351(a) | 2.5MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | May 24, 2018 | Original | 1649 | 001 | CDER | May 24, 2025 | ||||||||||
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BioMarin Pharmaceutical Inc. | 761079 | Palynziq | pegvaliase-pqpz | 351(a) | 10MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | May 24, 2018 | Original | 1649 | 002 | CDER | May 24, 2025 | ||||||||||
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BioMarin Pharmaceutical Inc. | 761079 | Palynziq | pegvaliase-pqpz | 351(a) | 20MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | May 24, 2018 | Original | 1649 | 003 | CDER | May 24, 2025 | ||||||||||
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VIVUS LLC | 022523 | Pancreaze | pancrelipase | 351(a) | 4,200USP UNITS; 14,200USP UNITS; 24,600USP UNITS | Capsule, Delayed Release | Oral | Rx | Licensed | April 12, 2010 | Original | 2197 | 001 | CDER | ||||||||||||
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VIVUS LLC | 022523 | Pancreaze | pancrelipase | 351(a) | 10,500USP UNITS; 35,500USP UNITS; 61,500USP UNITS | Capsule, Delayed Release | Oral | Rx | Licensed | April 12, 2010 | Original | 2197 | 002 | CDER | ||||||||||||
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VIVUS LLC | 022523 | Pancreaze | pancrelipase | 351(a) | 16,800USP UNITS; 56,800USP UNITS; 98,400USP UNITS | Capsule, Delayed Release | Oral | Rx | Licensed | April 12, 2010 | Original | 2197 | 003 | CDER | ||||||||||||
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VIVUS LLC | 022523 | Pancreaze | pancrelipase | 351(a) | 21,000USP UNITS; 54,700USP UNITS; 83,900USP UNITS | Capsule, Delayed Release | Oral | Rx | Licensed | April 12, 2010 | Original | 2197 | 004 | CDER | ||||||||||||
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VIVUS LLC | 022523 | Pancreaze | pancrelipase | 351(a) | 2,600USP UNITS; 8,800USP UNITS; 15,200USP UNITS | Capsule, Delayed Release | Oral | Rx | Licensed | March 7, 2014 | 4 | Supplement | 2197 | 005 | CDER | |||||||||||
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VIVUS LLC | 022523 | Pancreaze | pancrelipase | 351(a) | 37,000USP UNITS; 97,300USP UNITS; 149,900USP UNITS | Capsule, Delayed Release | Oral | Rx | Licensed | April 26, 2021 | 16 | Supplement | 2197 | 006 | CDER | |||||||||||
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Recordati Rare Diseases, Inc. | 101246 | Panhematin | Hemin for Injection | 351(a) | 350MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 20, 1983 | 5350 | Supplement | 1899 | 001 | CBER | July 20, 1990 | |||||||||
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Octapharma Pharmazeutika Produktionsges.m.b.H. | 125587 | Panzyga | Immune Globulin Intravenous (Human)-ifas | 351(a) | 1G ML | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | August 2, 2018 | 0 | Original | 1646 | 001 | CBER | ||||||||||
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Octapharma Pharmazeutika Produktionsges.m.b.H. | 125587 | Panzyga | Immune Globulin Intravenous (Human)-ifas | 351(a) | 2.5G ML | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | August 2, 2018 | 0 | Original | 1646 | 002 | CBER | ||||||||||
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Octapharma Pharmazeutika Produktionsges.m.b.H. | 125587 | Panzyga | Immune Globulin Intravenous (Human)-ifas | 351(a) | 30 G ML | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | August 2, 2018 | 0 | Original | 1646 | 003 | CBER | ||||||||||
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Octapharma Pharmazeutika Produktionsges.m.b.H. | 125587 | Panzyga | Immune Globulin Intravenous (Human)-ifas | 351(a) | 20G ML | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | August 2, 2018 | 0 | Original | 1646 | 004 | CBER | ||||||||||
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Octapharma Pharmazeutika Produktionsges.m.b.H. | 125587 | Panzyga | Immune Globulin Intravenous (Human)-ifas | 351(a) | 10G ML | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | August 2, 2018 | 0 | Original | 1646 | 005 | CBER | ||||||||||
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Octapharma Pharmazeutika Produktionsges.m.b.H. | 125587 | Panzyga | Immune Globulin Intravenous (Human)-ifas | 351(a) | 5G ML | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | August 2, 2018 | 0 | Original | 1646 | 006 | CBER | ||||||||||
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Precigen, Inc. | 125832 | PAPZIMEOS | zopapogene imadenovec-drba | 351(a) | 5x10^11PARTICLE UNITS | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | August 14, 2025 | 0 | Original | 2364 | 001 | CBER | ||||||||||
|
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Amgen Inc. | 761298 | Pavblu | aflibercept-ayyh | 351(k) Biosimilar | 2MG/0.05ML | Injection | Intravitreal | Single-Dose Vial | Rx | Licensed | August 23, 2024 | aflibercept | Eylea | Original | 1080 | 001 | CDER | |||||||||
|
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Amgen Inc. | 761298 | Pavblu | aflibercept-ayyh | 351(k) Biosimilar | 2MG/0.05ML | Injection | Intravitreal | Pre-Filled Syringe | Rx | Licensed | August 23, 2024 | aflibercept | Eylea | Original | 1080 | 002 | CDER | |||||||||
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GlaxoSmithKline Biologicals | 103907 | Pediarix | Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine | 351(a) | 0.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | December 13, 2002 | 0 | Original | 1617 | 001 | CBER | ||||||||||
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Merck Sharp & Dohme LLC | 103237 | Pedvaxhib | Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) | 351(a) | 7.5UG/.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | December 20, 1989 | 0 | Original | 0002 | 001 | CBER | ||||||||||
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|
pharmaand GmbH | 103964 | Pegasys | peginterferon alfa-2a | 351(a) | 180MCG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | October 16, 2002 | Original | 2291 | 001 | CDER | |||||||||||
|
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pharmaand GmbH | 103964 | Pegasys | peginterferon alfa-2a | 351(a) | 180MCG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | January 7, 2004 | 5011 | Supplement | 2291 | 002 | CDER | ||||||||||
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|
pharmaand GmbH | 103964 | Pegasys | peginterferon alfa-2a | 351(a) | 180MCG/0.5ML | Injection | Subcutaneous | Autoinjector | Disc | Licensed | September 29, 2011 | 5204 | Supplement | 2291 | 003 | CDER | ||||||||||
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pharmaand GmbH | 103964 | Pegasys | peginterferon alfa-2a | 351(a) | 135MCG/0.5ML | Injection | Subcutaneous | Autoinjector | Disc | Licensed | September 29, 2011 | 5204 | Supplement | 2291 | 004 | CDER | ||||||||||
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Hoffmann-La Roche Inc. | 125083 | Pegasys Copegus Combination Pack | peginterferon alfa-2a and ribavirin | 351(a) | 180MCG/0.5ML & 800MG | Disc | Voluntarily Revoked | June 4, 2004 | Original | 0136 | 001 | CDER | ||||||||||||||
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Hoffmann-La Roche Inc. | 125083 | Pegasys Copegus Combination Pack | peginterferon alfa-2a and ribavirin | 351(a) | 180MCG/0.5ML &1000MG | Disc | Voluntarily Revoked | June 4, 2004 | Original | 0136 | 002 | CDER | ||||||||||||||
|
|
Hoffmann-La Roche Inc. | 125083 | Pegasys Copegus Combination Pack | peginterferon alfa-2a and ribavirin | 351(a) | 180MCG/0.5ML & 1200MG | Disc | Voluntarily Revoked | June 4, 2004 | Original | 0136 | 003 | CDER | ||||||||||||||
|
|
Merck Sharp & Dohme LLC | 103949 | Pegintron | peginterferon alfa-2b | 351(a) | 50MCG/0.5ML | Injection | Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | January 19, 2001 | Original | 0002 | 001 | CDER | |||||||||||
|
|
Merck Sharp & Dohme LLC | 103949 | Pegintron | peginterferon alfa-2b | 351(a) | 80MCG/0.5ML | Injection | Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | January 19, 2001 | Original | 0002 | 007 | CDER | |||||||||||
|
|
Merck Sharp & Dohme LLC | 103949 | Pegintron | peginterferon alfa-2b | 351(a) | 120MCG/0.5ML | Injection | Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | January 19, 2001 | Original | 0002 | 009 | CDER | |||||||||||
|
|
Merck Sharp & Dohme LLC | 103949 | Pegintron | peginterferon alfa-2b | 351(a) | 150MCG/0.5ML | Injection | Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | January 19, 2001 | Original | 0002 | 011 | CDER | |||||||||||
|
|
Merck Sharp & Dohme LLC | 103949 | Pegintron | peginterferon alfa-2b | 351(a) | 50MCG/0.5ML | Injection | Subcutaneous | Autoinjector | Disc | Voluntarily Revoked | January 19, 2001 | Original | 0002 | 005 | CDER | |||||||||||
|
|
Merck Sharp & Dohme LLC | 103949 | Pegintron | peginterferon alfa-2b | 351(a) | 80MCG/0.5ML | Injection | Subcutaneous | Autoinjector | Disc | Voluntarily Revoked | January 19, 2001 | Original | 0002 | 006 | CDER | |||||||||||
|
|
Merck Sharp & Dohme LLC | 103949 | Pegintron | peginterferon alfa-2b | 351(a) | 120MCG/0.5ML | Injection | Subcutaneous | Autoinjector | Disc | Voluntarily Revoked | January 19, 2001 | Original | 0002 | 008 | CDER | |||||||||||
|
|
Merck Sharp & Dohme LLC | 103949 | Pegintron | peginterferon alfa-2b | 351(a) | 150MCG/0.5ML | Injection | Subcutaneous | Autoinjector | Disc | Voluntarily Revoked | January 19, 2001 | Original | 0002 | 010 | CDER | |||||||||||
|
|
Schering Corporation a subsidiary of Merck & Co., Inc. | 125196 | PegIntron/ Rebetol Combo Pack | peginterferon alfa-2b and ribavirin | 351(a) | 50MCG/0.5ML & 200MG | Disc | Voluntarily Revoked | June 13, 2008 | Original | 0994 | 001 | CDER | ||||||||||||||
|
|
Schering Corporation a subsidiary of Merck & Co., Inc. | 125196 | PegIntron/ Rebetol Combo Pack | peginterferon alfa-2b and ribavirin | 351(a) | 80MCG/0.5ML & 200MG | Disc | Voluntarily Revoked | June 13, 2008 | Original | 0994 | 002 | CDER | ||||||||||||||
|
|
Schering Corporation a subsidiary of Merck & Co., Inc. | 125196 | PegIntron/ Rebetol Combo Pack | peginterferon alfa-2b and ribavirin | 351(a) | 120MCG/0.5ML & 200MG | Disc | Voluntarily Revoked | June 13, 2008 | Original | 0994 | 003 | CDER | ||||||||||||||
|
|
Schering Corporation a subsidiary of Merck & Co., Inc. | 125196 | PegIntron/ Rebetol Combo Pack | peginterferon alfa-2b and ribavirin | 351(a) | 150MCG/0.5ML & 200MG | Disc | Voluntarily Revoked | June 13, 2008 | Original | 0994 | 004 | CDER | ||||||||||||||
|
|
Pfizer Ireland Pharmaceuticals Unlimited Company | 125770 | PENBRAYA | Meningococcal Groups A, B, C, W, and Y Vaccine | 351(a) | 5UG | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | October 20, 2023 | 0 | Original | 2060 | 001 | CBER | ||||||||||
|
|
GlaxoSmithKline Biologicals | 125819 | PENMENVY | Meningococcal Groups A, B, C, W and Y Vaccine | 351(a) | 25UG/0.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | February 14, 2025 | 0 | Original | 1617 | 001 | CBER | ||||||||||
|
|
Sanofi Pasteur Limited | 125145 | Pentacel | Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine | 351(a) | 0.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | June 20, 2008 | 0 | Original | 1726 | 001 | CBER | ||||||||||
|
|
EMD Serono, Inc. | 017646 | Pergonal | menotropins | 351(a) | 75IU | For Injection | Subcutaneous, Intramuscular | Single-Dose Vial | Disc | Licensed | August 22, 1975 | Original | 1773 | 001 | CDER | |||||||||||
|
|
EMD Serono, Inc. | 017646 | Pergonal | menotropins | 351(a) | 150IU | For Injection | Subcutaneous, Intramuscular | Single-Dose Vial | Disc | Licensed | May 20, 1985 | 22 | Supplement | 1773 | 002 | CDER | ||||||||||
|
|
Genentech, Inc. | 125409 | Perjeta | pertuzumab | 351(a) | 420MG/14ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 8, 2012 | Original | 1048 | 001 | CDER | June 8, 2012 | June 8, 2024 | Yes | ||||||||
|
|
Digestive Care, Inc. | 022175 | Pertzye | pancrelipase | 351(a) | 8,000USP UNITS; 28,750USP UNITS; 30,250USP UNITS | Capsule, Delayed Release | Oral | Rx | Licensed | May 17, 2012 | Original | 2184 | 001 | CDER | ||||||||||||
|
|
Digestive Care, Inc. | 022175 | Pertzye | pancrelipase | 351(a) | 16,000USP UNITS; 57,500USP UNITS; 60,500USP UNITS | Capsule, Delayed Release | Oral | Rx | Licensed | May 17, 2012 | Original | 2184 | 002 | CDER | ||||||||||||
|
|
Digestive Care, Inc. | 022175 | Pertzye | pancrelipase | 351(a) | 4,000USP UNITS; 14,375USP UNITS; 15,125USP UNITS | Capsule, Delayed Release | Oral | Rx | Licensed | October 6, 2016 | 3 | Supplement | 2184 | 003 | CDER | |||||||||||
|
|
Digestive Care, Inc. | 022175 | Pertzye | pancrelipase | 351(a) | 24,000USP UNITS; 86,250USP UNITS; 90,750USP UNITS | Capsule, Delayed Release | Oral | Rx | Licensed | July 13, 2017 | 5 | Supplement | 2184 | 004 | CDER | |||||||||||
|
|
ALK - Abello A/S | 103969 | Pharmalgen | Venoms, Honey Bee Venom | 351(a) | 100UG/ML | For Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | October 8, 1991 | 0 | Original | 1292 | 001 | CBER | ||||||||||
|
|
ALK - Abello A/S | 103969 | Pharmalgen | Venoms, Honey Bee Venom | 351(a) | 100UG/ML | For Injection | Intradermal | Multi-Dose Vial | Disc | Voluntarily Revoked | October 8, 1991 | 0 | Original | 1292 | 002 | CBER | ||||||||||
|
|
ALK - Abello A/S | 103970 | Pharmalgen | Venoms, Mixed Vespid Venom Protein | 351(a) | 300UG/ML | For Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | October 8, 1991 | 0 | Original | 1292 | 001 | CBER | ||||||||||
|
|
ALK - Abello A/S | 103970 | Pharmalgen | Venoms, Mixed Vespid Venom Protein | 351(a) | 300UG/ML | For Injection | Intradermal | Multi-Dose Vial | Disc | Voluntarily Revoked | October 8, 1991 | 0 | Original | 1292 | 002 | CBER | ||||||||||
|
|
ALK - Abello A/S | 103971 | Pharmalgen | Venoms, Wasp Venom Protein | 351(a) | 100UG/ML | For Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | October 8, 1991 | 0 | Original | 1292 | 001 | CBER | ||||||||||
|
|
ALK - Abello A/S | 103971 | Pharmalgen | Venoms, Wasp Venom Protein | 351(a) | 100UG/ML | For Injection | Intradermal | Multi-Dose Vial | Disc | Voluntarily Revoked | October 8, 1991 | 0 | Original | 1292 | 002 | CBER | ||||||||||
|
|
ALK - Abello A/S | 103972 | Pharmalgen | Venoms, White Faced Hornet Venom Protein | 351(a) | 100UG/ML | For Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | October 8, 1991 | 0 | Original | 1292 | 001 | CBER | ||||||||||
|
|
ALK - Abello A/S | 103972 | Pharmalgen | Venoms, White Faced Hornet Venom Protein | 351(a) | 100UG/ML | For Injection | Intradermal | Multi-Dose Vial | Disc | Voluntarily Revoked | October 8, 1991 | 0 | Original | 1292 | 002 | CBER | ||||||||||
|
|
ALK - Abello A/S | 103973 | Pharmalgen | Venoms, Yellow Hornet Venom Protein | 351(a) | 100UG/ML | For Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | October 8, 1991 | 0 | Original | 1292 | 001 | CBER | ||||||||||
|
|
ALK - Abello A/S | 103973 | Pharmalgen | Venoms, Yellow Hornet Venom Protein | 351(a) | 100UG/ML | For Injection | Intradermal | Multi-Dose Vial | Disc | Voluntarily Revoked | October 8, 1991 | 0 | Original | 1292 | 002 | CBER | ||||||||||
|
|
ALK - Abello A/S | 103974 | Pharmalgen | Venoms, Yellow Jacket Venom Protein | 351(a) | 100UG/ML | For Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | October 8, 1991 | 0 | Original | 1292 | 001 | CBER | ||||||||||
|
|
ALK - Abello A/S | 103974 | Pharmalgen | Venoms, Yellow Jacket Venom Protein | 351(a) | 100UG/ML | For Injection | Intradermal | Multi-Dose Vial | Disc | Voluntarily Revoked | October 8, 1991 | 0 | Original | 1292 | 002 | CBER | ||||||||||
|
|
Genentech, Inc. | 761170 | Phesgo | pertuzumab, trastuzumab, and hyaluronidase-zzxf | 351(a) | 1,200MG, 600MG, 30,000UNITS/15ML (80MG, 40MG, 2,000UNITS/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | June 29, 2020 | Original | 1048 | 001 | CDER | |||||||||||
|
|
Genentech, Inc. | 761170 | Phesgo | pertuzumab, trastuzumab, and hyaluronidase-zzxf | 351(a) | 600MG, 600MG, 20,000UNITS/10ML (60MG, 60MG, 2,000UNITS/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | June 29, 2020 | Original | 1048 | 002 | CDER | |||||||||||
|
|
Genentech, Inc. | 761388 | Piasky | crovalimab-akkz | 351(a) | 340MG/2ML (170MG/ML) | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | June 20, 2024 | Original | 1048 | 001 | CDER | June 20, 2031 | ||||||||||
|
|
Grifols Therapeutics LLC | 101140 | Plasmanate | Plasma Protein Fraction (Human) | 351(a) | 25G/500ML | Injection | Intravenous | Single-Dose Vial | Disc | Licensed | October 2, 1958 | 0 | Original | 1871 | 001 | CBER | ||||||||||
|
|
Grifols Therapeutics LLC | 101140 | Plasmanate | Plasma Protein Fraction (Human) | 351(a) | 2.5G/50ML | Injection | Intravenous | Single-Dose Vial | Disc | Licensed | October 2, 1958 | 0 | Original | 1871 | 002 | CBER | ||||||||||
|
|
Grifols Therapeutics LLC | 101140 | Plasmanate | Plasma Protein Fraction (Human) | 351(a) | 12.5G/250ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 2, 1958 | 0 | Original | 1871 | 003 | CBER | ||||||||||
|
|
Biogen Inc. | 125499 | Plegridy | peginterferon beta-1a | 351(a) | 125MCG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | August 15, 2014 | Original | 1697 | 001 | CDER | |||||||||||
|
|
Biogen Inc. | 125499 | Plegridy | peginterferon beta-1a | 351(a) | 63MCG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | August 15, 2014 | Original | 1697 | 002 | CDER | |||||||||||
|
|
Biogen Inc. | 125499 | Plegridy | peginterferon beta-1a | 351(a) | 94MCG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | August 15, 2014 | Original | 1697 | 003 | CDER | |||||||||||
|
|
Biogen Inc. | 125499 | Plegridy | peginterferon beta-1a | 351(a) | 125MCG/0.5ML | Injection | Subcutaneous, Intramuscular | Pre-Filled Syringe | Rx | Licensed | August 15, 2014 | Original | 1697 | 004 | CDER | |||||||||||
|
|
Biogen Inc. | 125499 | Plegridy | peginterferon beta-1a | 351(a) | 63MCG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | August 15, 2014 | Original | 1697 | 005 | CDER | |||||||||||
|
|
Biogen Inc. | 125499 | Plegridy | peginterferon beta-1a | 351(a) | 94MCG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | August 15, 2014 | Original | 1697 | 006 | CDER | |||||||||||
|
|
Merck Sharp & Dohme LLC | 101094 | Pneumovax 23 | Pneumococcal Vaccine, Polyvalent | 351(a) | 25UG/.5ML | Injection | Intramuscular | Vial | Rx | Licensed | November 21, 1977 | 0 | Original | 0002 | 001 | CBER | ||||||||||
|
|
Merck Sharp & Dohme LLC | 101094 | Pneumovax 23 | Pneumococcal Vaccine, Polyvalent | 351(a) | 25UG/.5ML | Injection | Subcutaneous | Vial | Rx | Licensed | November 21, 1977 | 0 | Original | 0002 | 002 | CBER | ||||||||||
|
|
Shanghai Henlius Biotech, Inc. | 761450 | Poherdy | pertuzumab-dpzb | 351(k) Interchangeable | 420MG/14ML (30MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 13, 2025 | November 13, 2025 | pertuzumab | Perjeta | Original | 2354 | 001 | CDER | Date TBD | |||||||
|
|
Sanofi Pasteur Limited | 103940 | Poliovax | Poliovirus Vaccine Inactivated (Human Diploid Cell) | 351(a) | 0.5ML | Injection | Subcutaneous | Vial | Disc | Licensed | February 24, 2000 | 0 | Original | 1726 | 001 | CBER | ||||||||||
|
|
Sanofi Pasteur Limited | 103940 | Poliovax | Poliovirus Vaccine Inactivated (Human Diploid Cell) | 351(a) | 0.5ML | Injection | Intramuscular | Vial | Disc | Licensed | February 24, 2000 | 0 | Original | 1726 | 002 | CBER | ||||||||||
|
|
Genentech, Inc. | 761121 | Polivy | polatuzumab vedotin-piiq | 351(a) | 140MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 10, 2019 | Original | 1048 | 001 | CDER | April 19, 2030 | ||||||||||
|
|
Genentech, Inc. | 761121 | Polivy | polatuzumab vedotin-piiq | 351(a) | 30MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | September 18, 2020 | 3 | Supplement | 1048 | 002 | CDER | April 19, 2030 | |||||||||
|
|
Amicus Therapeutics US, LLC | 761204 | Pombiliti | cipaglucosidase alfa-atga | 351(a) | 105MG | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | September 28, 2023 | Original | 2224 | 001 | CDER | |||||||||||
|
|
Eli Lilly and Company | 125547 | Portrazza | necitumumab | 351(a) | 800MG/50ML (16MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 24, 2015 | Original | 1891 | 001 | CDER | November 24, 2022 | ||||||||||
|
|
Kyowa Kirin, Inc. | 761051 | Poteligeo | mogamulizumab-kpkc | 351(a) | 20MG/5ML (4MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 8, 2018 | Original | 2077 | 001 | CDER | August 8, 2025 | ||||||||||
|
|
Regeneron Pharmaceuticals, Inc. | 125559 | Praluent | alirocumab | 351(a) | 75MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | July 24, 2015 | Original | 1760 | 001 | CDER | April 1, 2028 | ||||||||||
|
|
Regeneron Pharmaceuticals, Inc. | 125559 | Praluent | alirocumab | 351(a) | 150MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | July 24, 2015 | Original | 1760 | 002 | CDER | April 1, 2028 | ||||||||||
|
|
Regeneron Pharmaceuticals, Inc. | 125559 | Praluent | alirocumab | 351(a) | 75MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | July 24, 2015 | Original | 1760 | 003 | CDER | April 1, 2028 | ||||||||||
|
|
Regeneron Pharmaceuticals, Inc. | 125559 | Praluent | alirocumab | 351(a) | 150MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | July 24, 2015 | Original | 1760 | 004 | CDER | April 1, 2028 | ||||||||||
|
|
Boehringer Ingelheim Pharmaceuticals, Inc. | 761025 | Praxbind | idarucizumab | 351(a) | 2.5G/50ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 16, 2015 | Original | 2006 | 001 | CDER | October 16, 2022 | ||||||||||
|
|
AllerQuest, LLC | 050114 | Pre-Pen | benzylpenicilloyl polylysine | 351(a) | 0.25ML | Injection | Intradermal | Ampule | Rx | Licensed | July 25, 1974 | Original | 2265 | 001 | CDER | |||||||||||
|
|
Organon USA LLC, a subsidiary of Organon & Co. | 017692 | Pregnyl | chorionic gonadotropin | 351(a) | 10,000UNITS | For Injection | Intramuscular | Multi-Dose Vial | Rx | Licensed | October 20, 1976 | Original | 2331 | 001 | CDER | |||||||||||
|
|
VBI Vaccines (Delaware), Inc. | 125737 | Prehevbrio | Hepatitis B Vaccine (Recombinant) | 351(a) | 10UG/ML | For Injection | Intramuscular | Single-Dose Vial | Disc | Licensed | November 30, 2021 | 0 | Original | 2219 | 001 | CBER | November 30, 2021 | November 30, 2033 | ||||||||
|
|
Wyeth Pharmaceuticals LLC | 103905 | prevnar | Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) | 351(a) | 0.5ML/VIAL | Injection | Intramuscular | Pre-Filled Syringe | Rx | Voluntarily Revoked | February 17, 2000 | 0 | Original | 0003 | 001 | CBER | ||||||||||
|
|
Wyeth Pharmaceuticals LLC | 125324 | Prevnar 13 | Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) | 351(a) | 0.5ML | Injection | Intramuscular | Pre-Filled Syringe | Disc | Licensed | February 24, 2010 | 0 | Original | 0003 | 001 | CBER | ||||||||||
|
|
Wyeth Pharmaceuticals LLC | 125731 | Prevnar 20 | Pneumococcal 20-valent Conjugate Vaccine | 351(a) | 0.5 ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | June 8, 2021 | 0 | Original | 0003 | 001 | CBER | June 8, 2021 | June 8, 2033 | ||||||||
|
|
GlaxoSmithKline Biologicals | 125748 | PRIORIX | Measles, Mumps and Rubella Vaccine Live | 351(a) | 3.4, 4.2 and 3.3LOG10 | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | June 3, 2022 | 0 | Original | 1617 | 001 | CBER | ||||||||||
|
|
CSL Behring AG | 125201 | Privigen | Immune Globulin Intravenous (Human), 10% Liquid | 351(a) | 20G | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 26, 2007 | 0 | Original | 1766 | 001 | CBER | ||||||||||
|
|
CSL Behring AG | 125201 | Privigen | Immune Globulin Intravenous (Human), 10% Liquid | 351(a) | 10G | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 26, 2007 | 0 | Original | 1766 | 002 | CBER | ||||||||||
|
|
CSL Behring AG | 125201 | Privigen | Immune Globulin Intravenous (Human), 10% Liquid | 351(a) | 5G | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 26, 2007 | 0 | Original | 1766 | 003 | CBER | ||||||||||
|
|
CSL Behring AG | 125201 | Privigen | Immune Globulin Intravenous (Human), 10% Liquid | 351(a) | 2.5G | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 2, 2009 | 145 | Supplement | 1766 | 004 | CBER | ||||||||||
|
|
CSL Behring AG | 125201 | Privigen | Immune Globulin Intravenous (Human), 10% Liquid | 351(a) | 40G | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 7, 2013 | 443 | Supplement | 1766 | 005 | CBER | ||||||||||
|
|
Amgen Inc. | 103234 | Procrit | epoetin alfa | 351(a) | 40,000UNITS/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | Supplement | 1080 | 006 | CDER | December 31, 1997 | |||||||||||
|
|
Grifols Biologicals LLC | 102476 | Profilnine, Profilnine Hp, Profilnine Ht, Profilnine Sd | Factor IX Complex | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 20, 1981 | 0 | Original | 1694 | 001 | CBER | ||||||||||
|
|
Grifols Biologicals LLC | 102476 | Profilnine, Profilnine Hp, Profilnine Ht, Profilnine Sd | Factor IX Complex | 351(a) | 1500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 20, 1981 | 0 | Original | 1694 | 002 | CBER | ||||||||||
|
|
Grifols Biologicals LLC | 102476 | Profilnine, Profilnine Hp, Profilnine Ht, Profilnine Sd | Factor IX Complex | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 20, 1981 | 0 | Original | 1694 | 003 | CBER | ||||||||||
|
|
Grifols Therapeutics LLC | 103174 | prolastin,prolastin-c,prolastin-c liquid | Alpha-1-Proteinase Inhibitor (Human) | 351(a) | 1000MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 2, 1987 | 0 | Original | 1871 | 001 | CBER | December 2, 1994 | |||||||||
|
|
Grifols Therapeutics LLC | 103174 | prolastin,prolastin-c,prolastin-c liquid | Alpha-1-Proteinase Inhibitor (Human) | 351(a) | 500MG | For Injection | Intravenous | Single-Dose Vial | Disc | Licensed | December 2, 1987 | 0 | Original | 1871 | 002 | CBER | December 2, 1994 | |||||||||
|
|
Grifols Therapeutics LLC | 103174 | prolastin,prolastin-c,prolastin-c liquid | Alpha-1-Proteinase Inhibitor (Human) | 351(a) | 1000MG/20ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | September 8, 2017 | 6160 | Supplement | 1871 | 003 | CBER | December 2, 1994 | |||||||||
|
|
Grifols Therapeutics LLC | 103174 | prolastin,prolastin-c,prolastin-c liquid | Alpha-1-Proteinase Inhibitor (Human) | 351(a) | 4000MG/80ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 5, 2020 | 6314 | Supplement | 1871 | 004 | CBER | December 2, 1994 | |||||||||
|
|
Grifols Therapeutics LLC | 103174 | prolastin,prolastin-c,prolastin-c liquid | Alpha-1-Proteinase Inhibitor (Human) | 351(a) | 500MG/10ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 5, 2020 | 6314 | Supplement | 1871 | 005 | CBER | December 2, 1994 | |||||||||
|
|
Iovance Biotherapeutics Manufacturing LLC | 103293 | Proleukin | aldesleukin | 351(a) | 22MILLION INTERNATIONAL UNITS (1.3MG) | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 5, 1992 | Original | 2353 | 001 | CDER | January 9, 2005 | ||||||||||
|
|
Amgen Inc. | 125320 | Prolia | denosumab | 351(a) | 60MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | June 1, 2010 | Original | 1080 | 001 | CDER | Yes | ||||||||||
|
|
Amgen Inc. | 125320 | Prolia | denosumab | 351(a) | 60MG/ML | Injection | Subcutaneous | Single-Dose Vial | Disc | Licensed | June 1, 2010 | Original | 1080 | 002 | CDER | Yes | ||||||||||
|
|
Baxalta US Inc. | 103112 | Proplex-T; Bebulin | Factor IX Complex | 351(a) | 200-1200U/20ML | For Injection | Intravenous | Vial | Rx | Voluntarily Revoked | August 21, 1970 | 0 | Original | 2020 | 001 | CBER | ||||||||||
|
|
Merck Sharp & Dohme LLC | 125108 | Proquad | Measles, Mumps, Rubella and Varicella Virus Vaccine Live | 351(a) | 0.5ML | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | September 6, 2005 | 0 | Original | 0002 | 001 | CBER | ||||||||||
|
|
Merck Sharp & Dohme LLC | 125108 | Proquad | Measles, Mumps, Rubella and Varicella Virus Vaccine Live | 351(a) | 0.5ML | For Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | February 27, 2023 | 1128 | Supplement | 0002 | 002 | CBER | ||||||||||
|
|
Aytu BioScience, Inc. | 103608 | ProstaScint | capromab pendetide | 351(a) | 0.5MG/1ML | Injection | Intravenous | Single-Dose Vial | Disc | Licensed | October 28, 1996 | Original | 2035 | 001 | CDER | |||||||||||
|
|
Dendreon Pharmaceuticals LLC | 125197 | Provenge | sipuleucel-T | 351(a) | 50 M CD54 + ACTIVATED CELLS/250 ML | Injection | Intravenous | Bag | Rx | Licensed | April 29, 2010 | 0 | Original | 1749 | 001 | CBER | ||||||||||
|
|
Jubilant DraxImage Inc. | 017776 | Pulmolite | kit for the preparation of technetium Tc-99m albumin aggregated | 351(a) | 1MG/10MG/0.24MG/ 0.7MG/0.13MG/10MG | For Injectable Suspension | Intravenous | Vial | Disc | Licensed | November 16, 1976 | Original | 2186 | 001 | CDER | |||||||||||
|
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Cis Bio International | 210089 | Pulmotech MAA | kit for the preparation of technetium Tc-99m albumin aggregated | 351(a) | 2MG | For Injectable Suspension | Intravenous, Intraperitoneal | Multi-Dose Vial | Rx | Licensed | March 20, 2020 | Original | 2204 | 001 | CDER | |||||||||||
|
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Genentech, Inc. | 103532 | Pulmozyme | dornase alfa | 351(a) | 2.5MG/2.5ML (1MG/ML) | Solution | Inhalation | Ampule | Rx | Licensed | December 30, 1993 | Original | 1048 | 001 | CDER | December 30, 2000 | ||||||||||
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Samsung Bioepis Co., Ltd. | 761373 | Pyzchiva | ustekinumab-ttwe | 351(k) Interchangeable | 45MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | June 28, 2024 | April 30, 2025 | ustekinumab | Stelara | Original | 2046 | 001 | CDER | ||||||||
|
|
Samsung Bioepis Co., Ltd. | 761373 | Pyzchiva | ustekinumab-ttwe | 351(k) Interchangeable | 90MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | June 28, 2024 | April 30, 2025 | ustekinumab | Stelara | Original | 2046 | 002 | CDER | ||||||||
|
|
Samsung Bioepis Co., Ltd. | 761373 | Pyzchiva | ustekinumab-ttwe | 351(k) Interchangeable | 45MG/0.5ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | December 20, 2024 | April 30, 2025 | ustekinumab | Stelara | 2 | Supplement | 4 | 2046 | 003 | CDER | ||||||
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Samsung Bioepis Co., Ltd. | 761373 | Pyzchiva | ustekinumab-ttwe | 351(k) Interchangeable | 45MG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | June 27, 2025 | April 30, 2025 | ustekinumab | Stelara | 1 | Supplement | 2046 | 004 | CDER | |||||||
|
|
Samsung Bioepis Co., Ltd. | 761373 | Pyzchiva | ustekinumab-ttwe | 351(k) Interchangeable | 90MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | June 27, 2025 | April 30, 2025 | ustekinumab | Stelara | 1 | Supplement | 2046 | 005 | CDER | |||||||
|
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Samsung Bioepis Co., Ltd. | 761425 | Pyzchiva | ustekinumab-ttwe | 351(k) Interchangeable | 130MG/26ML (5MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 28, 2024 | April 30, 2025 | ustekinumab | Stelara | Original | 2046 | 001 | CDER | ||||||||
|
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Kedrion, S.p.A. | 125822 | QIVIGY | Immune Globulin Intravenous, Human-kthm, 10% Solution | 351(a) | 5G/50ML | Solution | Intravenous | Single-Dose Vial | Rx | Licensed | September 26, 2025 | 0 | Original | 1851 | 001 | CBER | ||||||||||
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Kedrion, S.p.A. | 125822 | QIVIGY | Immune Globulin Intravenous, Human-kthm, 10% Solution | 351(a) | 10G/100ML | Solution | Intravenous | Single-Dose Vial | Rx | Licensed | September 26, 2025 | 0 | Original | 1851 | 002 | CBER | ||||||||||
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Sanofi Pasteur Limited | 125525 | Quadracel | Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine | 351(a) | 0.5ML | Injection | Intramuscular | Single-Dose Vial | Disc | Licensed | March 24, 2015 | 0 | Original | 1726 | 001 | CBER | ||||||||||
|
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Sanofi Pasteur Limited | 125525 | Quadracel | Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine | 351(a) | 0.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | January 25, 2022 | 223 | Supplement | 1726 | 002 | CBER | ||||||||||
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Endo Global Aesthetics Limited | 761146 | Qwo | collagenase clostridium histolyticum-aaes | 351(a) | .92MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | July 6, 2020 | Original | 2136 | 001 | CDER | |||||||||||
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Endo Global Aesthetics Limited | 761146 | Qwo | collagenase clostridium histolyticum-aaes | 351(a) | 1.84MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | July 6, 2020 | Original | 2136 | 002 | CDER | |||||||||||
|
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Bavarian Nordic A/S | 103334 | Rabavert | Rabies Vaccine | 351(a) | 2.5IU | For Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | October 20, 1997 | 0 | Original | 2096 | 001 | CBER | ||||||||||
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ALK - Abello A/S | 125478 | Ragwitek | Short Ragweed Pollen Allergen Extract | 351(a) | 12 AMB A 1-UNITS/Tablet | Tablet | Sublingual | Blister Pack | Rx | Licensed | April 17, 2014 | 0 | Original | 1292 | 001 | CBER | ||||||||||
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Mallinckrodt Pharma IP Trading DAC | 125523 | Raplixa | Fibrin Sealant (Human) | 351(a) | 0.5G | Powder | Topical | Vial | Disc | Voluntarily Revoked | April 30, 2015 | 0 | Original | 2058 | 001 | CBER | ||||||||||
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Mallinckrodt Pharma IP Trading DAC | 125523 | Raplixa | Fibrin Sealant (Human) | 351(a) | 1G | Powder | Topical | Vial | Disc | Voluntarily Revoked | April 30, 2015 | 0 | Original | 2058 | 002 | CBER | ||||||||||
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Mallinckrodt Pharma IP Trading DAC | 125523 | Raplixa | Fibrin Sealant (Human) | 351(a) | 2G | Powder | Topical | Vial | Disc | Voluntarily Revoked | April 30, 2015 | 0 | Original | 2058 | 003 | CBER | ||||||||||
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Genentech, Inc. | 125075 | Raptiva | efalizumab | 351(a) | 125MG | Injection | Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | October 27, 2003 | 1048 | 001 | CDER | ||||||||||||
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EMD Serono, Inc. | 103780 | Rebif | interferon beta-1a | 351(a) | 22MCG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | March 7, 2002 | Original | 1773 | 001 | CDER | |||||||||||
|
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EMD Serono, Inc. | 103780 | Rebif | interferon beta-1a | 351(a) | 44MCG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | March 7, 2002 | Original | 1773 | 002 | CDER | |||||||||||
|
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EMD Serono, Inc. | 103780 | Rebif | interferon beta-1a | 351(a) | 8.8MCG/0.2ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | December 17, 2004 | 5052 | Supplement | 1773 | 003 | CDER | ||||||||||
|
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EMD Serono, Inc. | 103780 | Rebif | interferon beta-1a | 351(a) | 8.8MCG/0.2ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | December 21, 2012 | 5121 | Supplement | 1773 | 004 | CDER | ||||||||||
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EMD Serono, Inc. | 103780 | Rebif | interferon beta-1a | 351(a) | 22MCG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | December 21, 2012 | 5121 | Supplement | 1773 | 005 | CDER | ||||||||||
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EMD Serono, Inc. | 103780 | Rebif | interferon beta-1a | 351(a) | 44MCG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | December 21, 2012 | 5121 | Supplement | 1773 | 006 | CDER | ||||||||||
|
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Novo Nordisk Inc. | 125611 | Rebinyn | Coagulation Factor IX (Recombinant), GlycoPEGylated | 351(a) | 2000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 31, 2017 | 0 | Original | 1261 | 001 | CBER | ||||||||||
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Novo Nordisk Inc. | 125611 | Rebinyn | Coagulation Factor IX (Recombinant), GlycoPEGylated | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 31, 2017 | 0 | Original | 1261 | 002 | CBER | ||||||||||
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Novo Nordisk Inc. | 125611 | Rebinyn | Coagulation Factor IX (Recombinant), GlycoPEGylated | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 31, 2017 | 0 | Original | 1261 | 003 | CBER | ||||||||||
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Novo Nordisk Inc. | 125611 | Rebinyn | Coagulation Factor IX (Recombinant), GlycoPEGylated | 351(a) | 3000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 11, 2022 | 242 | Supplement | 1261 | 004 | CBER | ||||||||||
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Celgene Corporation, a Bristol-Myers Squibb Company | 761136 | Reblozyl | luspatercept-aamt | 351(a) | 25MG/VIAL | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | November 8, 2019 | Original | 2252 | 001 | CDER | August 28, 2030 | ||||||||||
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Celgene Corporation, a Bristol-Myers Squibb Company | 761136 | Reblozyl | luspatercept-aamt | 351(a) | 75MG/VIAL | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | November 8, 2019 | Original | 2252 | 002 | CDER | August 28, 2030 | ||||||||||
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Ferring Pharmaceuticals Inc. | 125739 | Rebyota | fecal microbiota, live-jslm | 351(a) | BETWEEN 1X10^8 AND 5X10^10CFU | Suspension | Rectal | Single-Use Bottle | Rx | Licensed | November 30, 2022 | 0 | Original | 2112 | 001 | CBER | November 30, 2022 | November 30, 2034 | November 30, 2029 | |||||||
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Merck Sharp & Dohme LLC | 101066 | Recombivax, Recombivax Hb | Hepatitis B Vaccine (Recombinant) | 351(a) | 5UG/ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | July 23, 1986 | 0 | Original | 0002 | 001 | CBER | ||||||||||
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Merck Sharp & Dohme LLC | 101066 | Recombivax, Recombivax Hb | Hepatitis B Vaccine (Recombinant) | 351(a) | 40UG/ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | July 23, 1986 | 0 | Original | 0002 | 002 | CBER | ||||||||||
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Merck Sharp & Dohme LLC | 101066 | Recombivax, Recombivax Hb | Hepatitis B Vaccine (Recombinant) | 351(a) | 10UG/ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | July 23, 1986 | 0 | Original | 0002 | 003 | CBER | ||||||||||
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Baxter Healthcare Corporation | 125248 | Recothrom | Thrombin topical (Recombinant) | 351(a) | 5000IU | For Solution | Topical | Single-Dose Vial | Rx | Licensed | January 17, 2008 | 0 | Original | 0140 | 001 | CBER | ||||||||||
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Baxter Healthcare Corporation | 125248 | Recothrom | Thrombin topical (Recombinant) | 351(a) | 20000IU | For Solution | Topical | Single-Dose Vial | Rx | Licensed | May 23, 2008 | 7 | Supplement | 0140 | 002 | CBER | ||||||||||
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Wyeth Pharmaceuticals LLC | 103779 | Refacto | Antihemophilic Factor (Recombinant) | 351(a) | 2000IU | For Injection | Intravenous | Vial | Disc | Licensed | June 27, 2001 | 5006 | Supplement | 0003 | 001 | CBER | ||||||||||
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Wyeth Pharmaceuticals LLC | 103779 | Refacto | Antihemophilic Factor (Recombinant) | 351(a) | 500IU | For Injection | Intravenous | Vial | Disc | Licensed | July 6, 2001 | 5000 | Supplement | 0003 | 002 | CBER | ||||||||||
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Wyeth Pharmaceuticals LLC | 103779 | Refacto | Antihemophilic Factor (Recombinant) | 351(a) | 250IU | For Injection | Intravenous | Vial | Disc | Licensed | July 6, 2001 | 5000 | Supplement | 0003 | 003 | CBER | ||||||||||
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Wyeth Pharmaceuticals LLC | 103779 | Refacto | Antihemophilic Factor (Recombinant) | 351(a) | 1000IU | For Injection | Intravenous | Vial | Disc | Licensed | July 6, 2001 | 5000 | Supplement | 0003 | 004 | CBER | ||||||||||
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StemCyte, Inc. | 125764 | regenecyte | HPC, Cord Blood | 351(a) | >/=1.25x10E6 VIABLE CD34+ CELLS/UNIT IN >/=9x10E8 TNCs/UNIT | Injection | Intravenous | Bag | Rx | Licensed | November 21, 2024 | 0 | Original | 2280 | 001 | CBER | ||||||||||
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Smith & Nephew, Inc. | 103691 | Regranex | becaplermin | 351(a) | 0.0001 | Gel | Topical | Tube | Rx | Licensed | December 16, 1997 | Original | 2004 | 001 | CDER | |||||||||||
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Kashiv BioSciences, LLC | 761082 | Releuko | filgrastim-ayow | 351(k) Biosimilar | 300MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | February 25, 2022 | filgrastim | Neupogen | Original | 2131 | 001 | CDER | |||||||||
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Kashiv BioSciences, LLC | 761082 | Releuko | filgrastim-ayow | 351(k) Biosimilar | 480MCG/1.6ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | February 25, 2022 | filgrastim | Neupogen | Original | 2131 | 002 | CDER | |||||||||
|
|
Kashiv BioSciences, LLC | 761082 | Releuko | filgrastim-ayow | 351(k) Biosimilar | 300MCG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | February 25, 2022 | filgrastim | Neupogen | Original | 2131 | 003 | CDER | |||||||||
|
|
Kashiv BioSciences, LLC | 761082 | Releuko | filgrastim-ayow | 351(k) Biosimilar | 480MCG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | February 25, 2022 | filgrastim | Neupogen | Original | 2131 | 004 | CDER | |||||||||
|
|
Janssen Biotech, Inc. | 103772 | Remicade | infliximab | 351(a) | 100MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 24, 1998 | Original | 1864 | 001 | CDER | September 23, 2018 | ||||||||||
|
|
Samsung Bioepis Co., Ltd. | 761054 | Renflexis | infliximab-abda | 351(k) Biosimilar | 100MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 21, 2017 | infliximab | Remicade | Original | 2046 | 001 | CDER | |||||||||
|
|
Janssen Biotech, Inc. | 103575 | Reopro | abciximab | 351(a) | 2MG/ML | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | December 22, 1994 | Original | 1864 | 001 | CDER | |||||||||||
|
|
Amgen Inc. | 125522 | Repatha | evolocumab | 351(a) | 140MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | August 27, 2015 | Original | 1080 | 001 | CDER | September 24, 2028 | ||||||||||
|
|
Amgen Inc. | 125522 | Repatha | evolocumab | 351(a) | 140MG/ML | Injection | Subcutaneous | Autoinjector | Disc | Licensed | August 27, 2015 | Original | 1080 | 002 | CDER | September 24, 2028 | ||||||||||
|
|
Amgen Inc. | 125522 | Repatha | evolocumab | 351(a) | 420MG/3.5ML | Injection | Subcutaneous | Autoinjector | Disc | Licensed | July 8, 2016 | 1 | Supplement | 1080 | 003 | CDER | September 24, 2028 | |||||||||
|
|
Ferring Pharmaceuticals Inc. | 021047 | Repronex | menotropins | 351(a) | 75IU | For Injection | Subcutaneous, Intramuscular | Single-Dose Vial | Disc | Licensed | August 27, 1999 | Original | 2112 | 001 | CDER | |||||||||||
|
|
Ferring Pharmaceuticals Inc. | 021047 | Repronex | menotropins | 351(a) | 150IU | For Injection | Subcutaneous, Intramuscular | Single-Dose Vial | Disc | Licensed | August 27, 1999 | Original | 2112 | 002 | CDER | |||||||||||
|
|
Hospira Inc., a Pfizer Company | 125545 | Retacrit | epoetin alfa-epbx | 351(k) Biosimilar | 2,000UNITS/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | May 15, 2018 | epoetin alfa | Procrit | Original | 1974 | 001 | CDER | |||||||||
|
|
Hospira Inc., a Pfizer Company | 125545 | Retacrit | epoetin alfa-epbx | 351(k) Biosimilar | 3,000UNITS/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | May 15, 2018 | epoetin alfa | Procrit | Original | 1974 | 002 | CDER | |||||||||
|
|
Hospira Inc., a Pfizer Company | 125545 | Retacrit | epoetin alfa-epbx | 351(k) Biosimilar | 4,000UNITS/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | May 15, 2018 | epoetin alfa | Procrit | Original | 1974 | 003 | CDER | |||||||||
|
|
Hospira Inc., a Pfizer Company | 125545 | Retacrit | epoetin alfa-epbx | 351(k) Biosimilar | 10,000UNITS/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | May 15, 2018 | epoetin alfa | Procrit | Original | 1974 | 004 | CDER | |||||||||
|
|
Hospira Inc., a Pfizer Company | 125545 | Retacrit | epoetin alfa-epbx | 351(k) Biosimilar | 40,000UNITS/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | May 15, 2018 | epoetin alfa | Procrit | Original | 1974 | 005 | CDER | |||||||||
|
|
Hospira Inc., a Pfizer Company | 125545 | Retacrit | epoetin alfa-epbx | 351(k) Biosimilar | 20,000UNITS/2ML (10,000UNITS/ML) | Injection | Intravenous, Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 30, 2020 | epoetin alfa | Procrit | 5 | Supplement | 1974 | 006 | CDER | ||||||||
|
|
Hospira Inc., a Pfizer Company | 125545 | Retacrit | epoetin alfa-epbx | 351(k) Biosimilar | 20,000UNITS/ML | Injection | Intravenous, Subcutaneous | Multi-Dose Vial | Rx | Licensed | June 30, 2020 | epoetin alfa | Procrit | 5 | Supplement | 1974 | 007 | CDER | ||||||||
|
|
Chiesi USA, Inc. | 103786 | Retavase | reteplase | 351(a) | 10UNITS | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 30, 1996 | Original | 2150 | 001 | CDER | |||||||||||
|
|
Sumitomo Pharma Switzerland GmbH | 125685 | Rethymic | allogeneic processed thymus tissue-agdc | 351(a) | SEMI-QUANTITATIVE | For Suspension | Implantation | Dish | Rx | Licensed | October 8, 2021 | 0 | Original | 2368 | 001 | CBER | October 8, 2021 | October 8, 2033 | October 8, 2028 | |||||||
|
|
Chiesi USA, Inc. | 761092 | Revcovi | elapegademase-lvlr | 351(a) | 2.4MG/1.5ML (1.6MG/ML) | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | October 5, 2018 | Original | 2150 | 001 | CDER | October 5, 2025 | ||||||||||
|
|
Eli Lilly and Company | 761215 | Rezvoglar | insulin glargine-aglr | 351(k) Interchangeable | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | December 17, 2021 | November 16, 2022 | insulin glargine | Lantus | Original | 1891 | 001 | CDER | ||||||||
|
|
CSL Behring AG | 125070 | Rhophylac | Rho(D) Immune Globulin Intravenous (Human) | 351(a) | 1500IU/ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | February 12, 2004 | 0 | Original | 1766 | 001 | CBER | ||||||||||
|
|
CSL Behring AG | 125070 | Rhophylac | Rho(D) Immune Globulin Intravenous (Human) | 351(a) | 1500IU/ML | Injection | Intravenous | Pre-Filled Syringe | Rx | Licensed | February 12, 2004 | 0 | Original | 1766 | 002 | CBER | ||||||||||
|
|
Amgen Inc. | 761140 | Riabni | rituximab-arrx | 351(k) Biosimilar | 100MG/10ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 17, 2020 | rituximab | Rituxan | Original | 1080 | 001 | CDER | |||||||||
|
|
Amgen Inc. | 761140 | Riabni | rituximab-arrx | 351(k) Biosimilar | 500MG/50ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 17, 2020 | rituximab | Rituxan | Original | 1080 | 002 | CDER | |||||||||
|
|
CSL Behring GmbH | 125317 | Riastap | Fibrinogen Concentrate (Human) | 351(a) | 900-1300MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | January 16, 2009 | 0 | Original | 1765 | 001 | CBER | January 16, 2016 | |||||||||
|
|
Genentech, Inc. | 103705 | Rituxan | rituximab | 351(a) | 100MG/10ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 26, 1997 | Original | 1048 | 001 | CDER | December 2, 2028 | Yes | |||||||||
|
|
Genentech, Inc. | 103705 | Rituxan | rituximab | 351(a) | 500MG/50ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 26, 1997 | Original | 1048 | 002 | CDER | December 2, 2028 | Yes | |||||||||
|
|
IDEC Pharmaceuticals Corp. | 103737 | Rituxan | rituximab | 351(a) | 100MG/10ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | February 19, 2002 | 1235 | 001 | CDER | ||||||||||||
|
|
IDEC Pharmaceuticals Corp. | 103737 | Rituxan | rituximab | 351(a) | 500MG/50ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | February 19, 2002 | 1235 | 002 | CDER | ||||||||||||
|
|
Genentech, Inc. | 761064 | Rituxan Hycela | rituximab and hyaluronidase human | 351(a) | 1,400MG/11.7ML; 23,400UNITS/11.7ML (120MG/2,000UNITS/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | June 22, 2017 | Original | 1048 | 001 | CDER | June 22, 2024 | ||||||||||
|
|
Genentech, Inc. | 761064 | Rituxan Hycela | rituximab and hyaluronidase human | 351(a) | 1,600MG/13.4ML; 26,800UNITS/13.4ML (120MG/2,000UNITS/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | June 22, 2017 | Original | 1048 | 002 | CDER | June 22, 2024 | ||||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 125446 | Rixubis | Coagulation Factor IX (Recombinant) | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 26, 2013 | 0 | Original | 1898 | 001 | CBER | September 12, 2021 | |||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 125446 | Rixubis | Coagulation Factor IX (Recombinant) | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 26, 2013 | 0 | Original | 1898 | 002 | CBER | September 12, 2021 | |||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 125446 | Rixubis | Coagulation Factor IX (Recombinant) | 351(a) | 250IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 26, 2013 | 0 | Original | 1898 | 003 | CBER | September 12, 2021 | |||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 125446 | Rixubis | Coagulation Factor IX (Recombinant) | 351(a) | 3000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 26, 2013 | 0 | Original | 1898 | 004 | CBER | September 12, 2021 | |||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 125446 | Rixubis | Coagulation Factor IX (Recombinant) | 351(a) | 2000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 26, 2013 | 0 | Original | 1898 | 005 | CBER | September 12, 2021 | |||||||||
|
|
Biomarin Pharmaceutical Inc. | 125720 | Roctavian | valoctocogene roxaparvovec-rvox | 351(a) | 16X 10E13GENOMES PER ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 29, 2023 | 0 | Original | 1649 | 001 | CBER | June 29, 2030 | |||||||||
|
|
Hoffmann-La Roche Inc. | 103145 | Roferon-A | interferon alfa-2a | 351(a) | 3MIU/0.5ML | For Injection | Subcutaneous | Pre-Filled Syringe | Disc | Voluntarily Revoked | June 4, 1986 | 0136 | 001 | CDER | ||||||||||||
|
|
Assertio Specialty Pharmaceuticals, LLC | 761148 | Rolvedon | eflapegrastim-xnst | 351(a) | 13.2MG/0.6ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | September 9, 2022 | Original | 2428 | 001 | CDER | |||||||||||
|
|
GlaxoSmithKline Biologicals | 125265 | Rotarix | Rotavirus Vaccine, Live, Oral | 351(a) | 1ML | For Suspension | Oral | Single-Dose Vial | Disc | Licensed | April 3, 2008 | 0 | Original | 1617 | 001 | CBER | ||||||||||
|
|
GlaxoSmithKline Biologicals | 125265 | Rotarix | Rotavirus Vaccine, Live, Oral | 351(a) | 106.0CCID50 | Suspension | Oral | Tube | Disc | Licensed | November 4, 2022 | 645 | Supplement | 1617 | 002 | CBER | ||||||||||
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GlaxoSmithKline Biologicals | 125265 | Rotarix | Rotavirus Vaccine, Live, Oral | 351(a) | 106.0CCID50 | Suspension | Oral | Oral Applicator | Rx | Licensed | November 4, 2022 | 645 | Supplement | 1617 | 003 | CBER | ||||||||||
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Merck Sharp & Dohme LLC | 125122 | Rotateq | Rotavirus Vaccine, Live, Oral, Pentavalent | 351(a) | 2.2X10E6 IU | Suspension | Oral | Tube | Rx | Licensed | February 3, 2006 | 0 | Original | 0002 | 001 | CBER | ||||||||||
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|
Pharming Americas BV | 125495 | Ruconest | C1 Esterase Inhibitor (Recombinant) | 351(a) | 2100IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 16, 2014 | 0 | Original | 2079 | 001 | CBER | July 16, 2014 | July 16, 2026 | July 16, 2021 | |||||||
|
|
Pfizer Ireland Pharmaceuticals | 761103 | Ruxience | rituximab-pvvr | 351(k) Biosimilar | 100MG/10ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 23, 2019 | rituximab | Rituxan | Original | 2060 | 001 | CDER | |||||||||
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Pfizer Ireland Pharmaceuticals | 761103 | Ruxience | rituximab-pvvr | 351(k) Biosimilar | 500MG/50ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 23, 2019 | rituximab | Rituxan | Original | 2060 | 002 | CDER | |||||||||
|
|
Janssen Biotech, Inc. | 761210 | Rybrevant | amivantamab-vmjw | 351(a) | 350MG/7ML (50MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 21, 2021 | Original | 1864 | 001 | CDER | |||||||||||
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Janssen Biotech, Inc. | 761484 | Rybrevant Faspro | amivantamab and hyaluronidase-lpuj | 351(a) | 1,600MG/10ML; 20,000UNITS/10ML (160MG/2,000UNITS/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | February 13, 2026 | Original | 1864 | 001 | CDER | |||||||||||
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Janssen Biotech, Inc. | 761484 | Rybrevant Faspro | amivantamab and hyaluronidase-lpuj | 351(a) | 2,240MG/14ML; 28,000UNITS/14ML (160MG/2,000UNITS/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | February 13, 2026 | Original | 1864 | 002 | CDER | |||||||||||
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|
Janssen Biotech, Inc. | 761484 | Rybrevant Faspro | amivantamab and hyaluronidase-lpuj | 351(a) | 2,400MG/15ML; 30,000UNITS (160MG/2,000UNITS/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | February 13, 2026 | Original | 1864 | 003 | CDER | |||||||||||
|
|
Janssen Biotech, Inc. | 761484 | Rybrevant Faspro | amivantamab and hyaluronidase-lpuj | 351(a) | 3,520MG/22ML; 44,000UNITS (160MG/2,000UNITS/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | February 13, 2026 | Original | 1864 | 004 | CDER | |||||||||||
|
|
Jazz Pharmaceuticals Ireland Limited | 761179 | Rylaze | asparaginase erwinia chrysanthemi (recombinant)-rywn | 351(a) | 10MG/0.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | June 30, 2021 | Original | 2167 | 001 | CDER | |||||||||||
|
|
Mesoblast, Inc. | 125706 | ryoncil | remestemcel-L-rknd | 351(a) | 6.68X10^CELL/ML | Suspension | Intravenous | Single-Dose Vial | Rx | Licensed | December 18, 2024 | 0 | Original | 2140 | 001 | CBER | December 18, 2024 | December 18, 2031 | ||||||||
|
|
Kedrion Biopharma Inc. | 125659 | Ryplazim | plasminogen, human-tvmh | 351(a) | 68.8MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 4, 2021 | 0 | Original | 1906 | 001 | CBER | June 4, 2021 | June 4, 2033 | June 4, 2028 | |||||||
|
|
UCB, Inc. | 761286 | Rystiggo | rozanolixizumab-noli | 351(a) | 420MG/3ML (140MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | June 14, 2024 | 1 | Supplement | 1736 | 002 | CDER | June 26, 2030 | |||||||||
|
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UCB, Inc. | 761286 | Rystiggo | rozanolixizumab-noli | 351(a) | 560MG/4ML (140MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | June 14, 2024 | 1 | Supplement | 1736 | 003 | CDER | June 26, 2030 | |||||||||
|
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UCB, Inc. | 761286 | Rystiggo | rozanolixizumab-noli | 351(a) | 840MG/6ML (140MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | June 14, 2024 | 1 | Supplement | 1736 | 004 | CDER | June 26, 2030 | |||||||||
|
|
UCB, Inc. | 761286 | Rystiggo | rozanolixizumab-noli | 351(a) | 280MG/2ML (140MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | June 26, 2023 | Original | 1736 | 001 | CDER | June 26, 2030 | ||||||||||
|
|
Evive Biotechnology Singapore PTE. LTD. | 761134 | Ryzneuta | efbemalenograstim alfa-vuxw | 351(a) | 20MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | November 16, 2023 | Original | 2248 | 001 | CDER | |||||||||||
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Novo Nordisk Inc. | 203313 | Ryzodeg 70/30 | insulin degludec and insulin aspart | 351(a) | 210UNITS/3ML (70UNITS/ML); 90UNIT/3ML (30UNITS/ML) | Injection | Subcutaneous | Autoinjector | Disc | Licensed | September 25, 2015 | Original | 1261 | 001 | CDER | |||||||||||
|
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EMD Serono, Inc. | 019764 | Saizen | somatropin | 351(a) | 6MG | For Injection | Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | October 8, 1996 | Original | 1773 | 001 | CDER | |||||||||||
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EMD Serono, Inc. | 019764 | Saizen | somatropin | 351(a) | 5MG | For Injection | Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | October 8, 1996 | Original | 1773 | 002 | CDER | |||||||||||
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EMD Serono, Inc. | 019764 | Saizen | somatropin | 351(a) | 8.8MG | For Injection | Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | August 29, 2000 | 3 | Supplement | 1773 | 003 | CDER | ||||||||||
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EMD Serono, Inc. | 019764 | Saizen | somatropin | 351(a) | 4MG | For Injection | Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | January 16, 2007 | 30 | Supplement | 1773 | 005 | CDER | ||||||||||
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Smith & Nephew, Inc. | 101995 | Santyl | collagenase | 351(a) | 250UNITS/GRAM | Ointment | Topical | Tube | Rx | Licensed | June 4, 1965 | Original | 2004 | 001 | CDER | |||||||||||
|
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AstraZeneca AB | 761123 | Saphnelo | anifrolumab-fnia | 351(a) | 300MG/2ML (150MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 30, 2021 | Original | 2059 | 001 | CDER | |||||||||||
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Sanofi-Aventis U.S. LLC | 761113 | Sarclisa | isatuximab-irfc | 351(a) | 100MG/5ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 2, 2020 | Original | 1752 | 001 | CDER | September 20, 2031 | ||||||||||
|
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Sanofi-Aventis U.S. LLC | 761113 | Sarclisa | isatuximab-irfc | 351(a) | 500MG/25ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 2, 2020 | Original | 1752 | 002 | CDER | September 20, 2031 | ||||||||||
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Alvotech USA Inc. | 761343 | Selarsdi | ustekinumab-aekn | 351(k) Interchangeable | 130MG/26ML (5MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 18, 2024 | April 30, 2025 | ustekinumab | Stelara | 2 | Supplement | 4 | 2225 | 003 | CDER | ||||||
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Alvotech USA Inc. | 761343 | Selarsdi | ustekinumab-aekn | 351(k) Interchangeable | 45MG/0.5ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | February 12, 2025 | April 30, 2025 | ustekinumab | Stelara | 5 | Supplement | 4 | 2225 | 004 | CDER | ||||||
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Alvotech USA Inc. | 761343 | Selarsdi | ustekinumab-aekn | 351(k) Interchangeable | 45MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | April 16, 2024 | April 30, 2025 | ustekinumab | Stelara | Original | 4 | 2225 | 001 | CDER | |||||||
|
|
Alvotech USA Inc. | 761343 | Selarsdi | ustekinumab-aekn | 351(k) Interchangeable | 90MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | April 16, 2024 | April 30, 2025 | ustekinumab | Stelara | Original | 4 | 2225 | 002 | CDER | |||||||
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Biocon Biologics Inc. | 761201 | Semglee | insulin glargine-yfgn | 351(k) Interchangeable | 1,000UNITS/10ML (100UNITS/ML) | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | July 28, 2021 | July 28, 2021 | insulin glargine | Lantus | Original | 2324 | 001 | CDER | 44880 | |||||||
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|
Biocon Biologics Inc. | 761201 | Semglee | insulin glargine-yfgn | 351(k) Interchangeable | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | July 28, 2021 | July 28, 2021 | insulin glargine | Lantus | Original | 2324 | 002 | CDER | 44880 | |||||||
|
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Mylan Pharmaceuticals Inc. | 210605 | Semglee | insulin glargine | 351(a) | 1,000UNITS/10ML (100 UNITS/ML) | Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | June 11, 2020 | Original | 2210 | 001 | CDER | |||||||||||
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|
Mylan Pharmaceuticals Inc. | 210605 | Semglee | insulin glargine | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Disc | Voluntarily Revoked | June 11, 2020 | Original | 2210 | 002 | CDER | |||||||||||
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EMD Serono, Inc. | 020604 | Serostim | somatropin | 351(a) | 6MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | August 23, 1996 | Original | 1773 | 001 | CDER | August 23, 2003 | ||||||||||
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EMD Serono, Inc. | 020604 | Serostim | somatropin | 351(a) | 5MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | August 23, 1996 | Original | 1773 | 002 | CDER | |||||||||||
|
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EMD Serono, Inc. | 020604 | Serostim | somatropin | 351(a) | 4MG | For Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | July 25, 1997 | 2 | Supplement | 1773 | 003 | CDER | ||||||||||
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EMD Serono, Inc. | 020604 | Serostim | somatropin | 351(a) | 6MG/0.5ML | Injection | Subcutaneous | Single-Dose Cartridge | Disc | Licensed | February 11, 2005 | 29 | Supplement | 1773 | 005 | CDER | ||||||||||
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Laboratoire Francais du Fractionnement et des Biotechnologies S.A. | 125641 | Sevenfact | coagulation factor VIIa (recombinant)-jncw | 351(a) | 1MG | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 1, 2020 | 0 | Original | 2061 | 001 | CBER | ||||||||||
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Laboratoire Francais du Fractionnement et des Biotechnologies S.A. | 125641 | Sevenfact | coagulation factor VIIa (recombinant)-jncw | 351(a) | 5MG | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 1, 2020 | 0 | Original | 2061 | 002 | CBER | ||||||||||
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Laboratoire Francais du Fractionnement et des Biotechnologies S.A. | 125641 | Sevenfact | coagulation factor VIIa (recombinant)-jncw | 351(a) | 2MG | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 20, 2024 | 128 | Supplement | 2061 | 003 | CBER | ||||||||||
|
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GlaxoSmithKline Biologicals | 125614 | Shingrix | Zoster Vaccine Recombinant, Adjuvanted | 351(a) | 0.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | October 20, 2017 | 0 | Original | 1617 | 001 | CBER | ||||||||||
|
|
GlaxoSmithKline Biologicals | 125614 | Shingrix | Zoster Vaccine Recombinant, Adjuvanted | 351(a) | 50UG | For Injection | Intramuscular | Vial | Rx | Licensed | July 23, 2021 | 398 | Supplement | 1617 | 002 | CBER | ||||||||||
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GlaxoSmithKline Biologicals | 125614 | Shingrix | Zoster Vaccine Recombinant, Adjuvanted | 351(a) | 50UG | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | July 16, 2025 | 1131 | Supplement | 1617 | 003 | CBER | ||||||||||
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Bausch Health Ireland, Limited | 761032 | Siliq | brodalumab | 351(a) | 210MG/1.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | February 15, 2017 | Original | 2365 | 001 | CDER | |||||||||||
|
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Alvotech USA Inc. | 761299 | Simlandi | adalimumab-ryvk | 351(k) Interchangeable | 20MG/0.2ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | June 26, 2024 | April 7, 2025 | adalimumab | Humira | 7 | Supplement | 13 | 2225 | 003 | CDER | ||||||
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|
Alvotech USA Inc. | 761299 | Simlandi | adalimumab-ryvk | 351(k) Interchangeable | 80MG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | June 26, 2024 | April 7, 2025 | adalimumab | Humira | 7 | Supplement | 13 | 2225 | 004 | CDER | ||||||
|
|
Alvotech USA Inc. | 761299 | Simlandi | adalimumab-ryvk | 351(k) Interchangeable | 80MG/0.8ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | February 14, 2025 | April 7, 2025 | adalimumab | Humira | 16 | Supplement | 20 | 2225 | 005 | CDER | ||||||
|
|
Alvotech USA Inc. | 761299 | Simlandi | adalimumab-ryvk | 351(k) Interchangeable | 40MG/0.4ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | February 23, 2024 | February 23, 2024 | adalimumab | Humira | Original | 2225 | 001 | CDER | 45797 | |||||||
|
|
Alvotech USA Inc. | 761299 | Simlandi | adalimumab-ryvk | 351(k) Interchangeable | 40MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | June 26, 2024 | June 26, 2024 | adalimumab | Humira | 7 | Supplement | 7 | 2225 | 002 | CDER | 45797 | |||||
|
|
Janssen Biotech, Inc. | 125289 | Simponi | golimumab | 351(a) | 50MG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | April 24, 2009 | Original | 1864 | 001 | CDER | Yes | ||||||||||
|
|
Janssen Biotech, Inc. | 125289 | Simponi | golimumab | 351(a) | 50MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | April 24, 2009 | Original | 1864 | 002 | CDER | Yes | ||||||||||
|
|
Janssen Biotech, Inc. | 125289 | Simponi | golimumab | 351(a) | 100MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | May 15, 2013 | 77 | Supplement | 1864 | 003 | CDER | Yes | |||||||||
|
|
Janssen Biotech, Inc. | 125289 | Simponi | golimumab | 351(a) | 100MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | May 15, 2013 | 77 | Supplement | 1864 | 004 | CDER | Yes | |||||||||
|
|
Janssen Biotech, Inc. | 125433 | Simponi Aria | golimumab | 351(a) | 50MG/4ML (12.5MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 18, 2013 | Original | 1864 | 001 | CDER | September 29, 2027 | Yes | |||||||||
|
|
Novartis Pharmaceuticals Corporation | 103764 | Simulect | basiliximab | 351(a) | 20MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 12, 1998 | Original | 1244 | 001 | CDER | May 12, 2005 | ||||||||||
|
|
Novartis Pharmaceuticals Corporation | 103764 | Simulect | basiliximab | 351(a) | 10MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | January 2, 2003 | 5037 | Supplement | 1244 | 002 | CDER | May 12, 2005 | |||||||||
|
|
AbbVie Inc. | 761105 | Skyrizi | risankizumab-rzaa | 351(a) | 75MG/0.83ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | April 23, 2019 | Original | 1889 | 001 | CDER | |||||||||||
|
|
AbbVie Inc. | 761105 | Skyrizi | risankizumab-rzaa | 351(a) | 150MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | April 26, 2021 | 9 | Supplement | 1889 | 002 | CDER | ||||||||||
|
|
AbbVie Inc. | 761105 | Skyrizi | risankizumab-rzaa | 351(a) | 150MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | April 26, 2021 | 10 | Supplement | 1889 | 003 | CDER | ||||||||||
|
|
AbbVie Inc. | 761105 | Skyrizi | risankizumab-rzaa | 351(a) | 360MG/2.4ML (150MG/ML) | Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | June 16, 2022 | 16 | Supplement | 1889 | 005 | CDER | ||||||||||
|
|
AbbVie Inc. | 761262 | Skyrizi | risankizumab-rzaa | 351(a) | 600MG/10ML (60MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 16, 2022 | Original | 1889 | 001 | CDER | |||||||||||
|
|
AbbVie Inc. | 761105 | Skyrizi | risankizumab-rzaa | 351(a) | 180MG/1.2ML (150MG/ML) | Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | September 23, 2022 | 18 | Supplement | 1889 | 004 | CDER | ||||||||||
|
|
AbbVie Inc. | 761105 | Skyrizi | risankizumab-rzaa | 351(a) | 90MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | March 22, 2023 | 24 | Supplement | 1889 | 006 | CDER | ||||||||||
|
|
AbbVie Inc. | 761105 | Skyrizi | risankizumab-rzaa | 351(a) | 180MG/1.2ML (150MG/ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | September 3, 2025 | 39 | Supplement | 1889 | 007 | CDER | ||||||||||
|
|
Genetix Biotherapeutics Inc. | 125755 | Skysona | elivaldogene autotemcel | 351(a) | 2-30 × 10^6 CELL/ML | Injection | Intravenous | Bag | Rx | Licensed | September 16, 2022 | 0 | Original | 2425 | 001 | CBER | September 16, 2022 | September 16, 2034 | September 16, 2029 | |||||||
|
|
Ascendis Pharma Endocrinology Division A/S | 761177 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 0.7MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | July 25, 2025 | 8 | Supplement | 2165 | 010 | CDER | ||||||||||
|
|
Ascendis Pharma Endocrinology Division A/S | 761177 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 1.4MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | July 25, 2025 | 8 | Supplement | 2165 | 011 | CDER | ||||||||||
|
|
Ascendis Pharma Endocrinology Division A/S | 761177 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 1.8MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | July 25, 2025 | 8 | Supplement | 2165 | 012 | CDER | ||||||||||
|
|
Ascendis Pharma Endocrinology Division A/S | 761177 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 2.1MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | July 25, 2025 | 8 | Supplement | 2165 | 013 | CDER | ||||||||||
|
|
Ascendis Pharma Endocrinology Division A/S | 761177 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 2.5MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | July 25, 2025 | 8 | Supplement | 2165 | 014 | CDER | ||||||||||
|
|
Ascendis Pharma Endocrinology Division A/S | 761177 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 3MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | August 25, 2021 | Original | 2165 | 001 | CDER | |||||||||||
|
|
Ascendis Pharma Endocrinology Division A/S | 761177 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 3.6MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | August 25, 2021 | Original | 2165 | 002 | CDER | |||||||||||
|
|
Ascendis Pharma Endocrinology Division A/S | 761177 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 4.3MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | August 25, 2021 | Original | 2165 | 003 | CDER | |||||||||||
|
|
Ascendis Pharma Endocrinology Division A/S | 761177 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 6.3MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | August 25, 2021 | Original | 2165 | 005 | CDER | |||||||||||
|
|
Ascendis Pharma Endocrinology Division A/S | 761177 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 7.6MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | August 25, 2021 | Original | 2165 | 006 | CDER | |||||||||||
|
|
Ascendis Pharma Endocrinology Division A/S | 761177 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 9.1MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | August 25, 2021 | Original | 2165 | 007 | CDER | |||||||||||
|
|
Ascendis Pharma Endocrinology Division A/S | 761177 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 11MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | August 25, 2021 | Original | 2165 | 008 | CDER | |||||||||||
|
|
Ascendis Pharma Endocrinology Division A/S | 761177 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 13.3MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | August 25, 2021 | Original | 2165 | 009 | CDER | |||||||||||
|
|
Ascendis Pharma Endocrinology Division A/S | 761177 | Skytrofa | lonapegsomatropin-tcgd | 351(a) | 5.2MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | August 25, 2021 | Original | 2165 | 004 | CDER | |||||||||||
|
|
Novo Nordisk Inc. | 761156 | Sogroya | somapacitan-beco | 351(a) | 10MG/1.5ML (6.7MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | August 28, 2020 | Original | 1261 | 001 | CDER | |||||||||||
|
|
Novo Nordisk Inc. | 761156 | Sogroya | somapacitan-beco | 351(a) | 5MG/1.5ML (3.3MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | October 1, 2021 | 1 | Supplement | 1261 | 002 | CDER | ||||||||||
|
|
Novo Nordisk Inc. | 761156 | Sogroya | somapacitan-beco | 351(a) | 15MG/1.5ML (10MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | April 28, 2023 | 5 | Supplement | 1261 | 003 | CDER | ||||||||||
|
|
Sanofi-Aventis U.S. LLC | 208673 | Soliqua 100/33 | insulin glargine and lixisenatide | 351(a) | 300UNITS/3ML (100UNITS/ML); 99MCG/3ML (33MCG/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | November 21, 2016 | Original | 1752 | 001 | CDER | |||||||||||
|
|
Alexion Pharmaceuticals, Inc. | 125166 | Soliris | eculizumab | 351(a) | 300MG/30ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 16, 2007 | Original | 1743 | 001 | CDER | June 27, 2026 | ||||||||||
|
|
Pharmacia & Upjohn Company LLC | 021106 | Somavert | pegvisomant | 351(a) | 10MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | March 25, 2003 | Original | 1216 | 001 | CDER | March 25, 2010 | ||||||||||
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Pharmacia & Upjohn Company LLC | 021106 | Somavert | pegvisomant | 351(a) | 15MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | March 25, 2003 | Original | 1216 | 002 | CDER | March 25, 2010 | ||||||||||
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Pharmacia & Upjohn Company LLC | 021106 | Somavert | pegvisomant | 351(a) | 20MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | March 25, 2003 | Original | 1216 | 003 | CDER | March 25, 2010 | ||||||||||
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Pharmacia & Upjohn Company LLC | 021106 | Somavert | pegvisomant | 351(a) | 25MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | July 31, 2014 | 44 | Supplement | 1216 | 004 | CDER | March 25, 2010 | |||||||||
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Pharmacia & Upjohn Company LLC | 021106 | Somavert | pegvisomant | 351(a) | 30MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | July 31, 2014 | 44 | Supplement | 1216 | 005 | CDER | March 25, 2010 | |||||||||
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Boehringer Ingelheim Pharmaceuticals, Inc. | 761244 | Spevigo | spesolimab-sbzo | 351(a) | 450MG/7.5ML (60MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | September 1, 2022 | Original | 2006 | 001 | CDER | March 18, 2031 | ||||||||||
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Boehringer Ingelheim Pharmaceuticals, Inc. | 761244 | Spevigo | spesolimab-sbzo | 351(a) | 150MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | March 18, 2024 | 3 | Supplement | 2006 | 002 | CDER | March 18, 2031 | |||||||||
|
|
Boehringer Ingelheim Pharmaceuticals, Inc. | 761244 | Spevigo | spesolimab-sbzo | 351(a) | 300MG/2ML (150MG/ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | May 28, 2025 | 4 | Supplement | 2006 | 003 | CDER | March 18, 2031 | |||||||||
|
|
Nielsen Bioscience, Inc | 125354 | Spherusol | Coccidioides immitis Spherule-Derived Skin Test Antigen | 351(a) | 1.0ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | July 29, 2011 | 0 | Original | 1903 | 001 | CBER | ||||||||||
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|
ModernaTX, Inc. | 125752 | Spikevax | COVID-19 Vaccine, mRNA | 351(a) | 100UG | Injection | Intramuscular | Multi-Dose Vial | Disc | Licensed | January 31, 2022 | 0 | Original | 2256 | 001 | CBER | ||||||||||
|
|
ModernaTX, Inc. | 125752 | Spikevax | COVID-19 Vaccine, mRNA | 351(a) | 50UG/0.5mL | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | September 11, 2023 | 68 | Supplement | 2256 | 002 | CBER | ||||||||||
|
|
ModernaTX, Inc. | 125752 | Spikevax | COVID-19 Vaccine, mRNA | 351(a) | 50UG | Injection | Intramuscular | Single-Dose Vial | Disc | Licensed | September 11, 2023 | 68 | Supplement | 2256 | 003 | CBER | ||||||||||
|
|
ModernaTX, Inc. | 125752 | Spikevax | COVID-19 Vaccine, mRNA | 351(a) | 50UG | Injection | Intramuscular | Multi-Dose Vial | Disc | Licensed | September 11, 2023 | 68 | Supplement | 2256 | 004 | CBER | ||||||||||
|
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ModernaTX, Inc. | 125752 | Spikevax | COVID-19 Vaccine, mRNA | 351(a) | 25UG/0.25mL | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | July 9, 2025 | 276 | Supplement | 2256 | 005 | CBER | ||||||||||
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Bio-Thera Solutions, Ltd. | 761419 | Starjemza | ustekinumab-hmny | 351(k) Interchangeable | 45MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | May 22, 2025 | May 22, 2025 | ustekinumab | Stelara | Original | 2218 | 001 | CDER | ||||||||
|
|
Bio-Thera Solutions, Ltd. | 761419 | Starjemza | ustekinumab-hmny | 351(k) Interchangeable | 90MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | May 22, 2025 | May 22, 2025 | ustekinumab | Stelara | Original | 2218 | 002 | CDER | ||||||||
|
|
Bio-Thera Solutions, Ltd. | 761419 | Starjemza | ustekinumab-hmny | 351(k) Interchangeable | 45MG/0.5ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | May 22, 2025 | May 22, 2025 | ustekinumab | Stelara | Original | 2218 | 003 | CDER | ||||||||
|
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Bio-Thera Solutions, Ltd. | 761419 | Starjemza | ustekinumab-hmny | 351(k) Interchangeable | 130MG/26ML (5MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 22, 2025 | May 22, 2025 | ustekinumab | Stelara | Original | 2218 | 004 | CDER | ||||||||
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Janssen Biotech, Inc. | 125261 | Stelara | ustekinumab | 351(a) | 45MG/0.5ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | September 25, 2009 | Original | 1864 | 001 | CDER | Yes | ||||||||||
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Janssen Biotech, Inc. | 125261 | Stelara | ustekinumab | 351(a) | 90MG/ML | Injection | Subcutaneous | Single-Dose Vial | Disc | Licensed | September 25, 2009 | Original | 1864 | 002 | CDER | Yes | ||||||||||
|
|
Janssen Biotech, Inc. | 125261 | Stelara | ustekinumab | 351(a) | 45MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | December 30, 2009 | 1 | Supplement | 1864 | 003 | CDER | Yes | |||||||||
|
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Janssen Biotech, Inc. | 125261 | Stelara | ustekinumab | 351(a) | 90MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | December 30, 2009 | 1 | Supplement | 1864 | 004 | CDER | Yes | |||||||||
|
|
Janssen Biotech, Inc. | 761044 | Stelara | ustekinumab | 351(a) | 130MG/26ML (5MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | September 23, 2016 | Original | 1864 | 001 | CDER | Yes | ||||||||||
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CELLTRION, Inc. | 761338 | Steqeyma | ustekinumab-stba | 351(k) Interchangeable | 90MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | December 17, 2024 | April 30, 2025 | ustekinumab | Stelara | Original | 1996 | 002 | CDER | ||||||||
|
|
CELLTRION, Inc. | 761338 | Steqeyma | ustekinumab-stba | 351(k) Interchangeable | 130MG/26ML (5MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 17, 2024 | April 30, 2025 | ustekinumab | Stelara | Original | 1996 | 003 | CDER | ||||||||
|
|
CELLTRION, Inc. | 761338 | Steqeyma | ustekinumab-stba | 351(k) Interchangeable | 45MG/0.5ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | June 12, 2025 | April 30, 2025 | ustekinumab | Stelara | 3 | Supplement | 1996 | 004 | CDER | |||||||
|
|
CELLTRION, Inc. | 761338 | Steqeyma | ustekinumab-stba | 351(k) Interchangeable | 45MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | December 17, 2024 | April 30, 2025 | ustekinumab | Stelara | Original | 1996 | 001 | CDER | ||||||||
|
|
Fresenius Kabi USA, LLC | 761173 | Stimufend | pegfilgrastim-fpgk | 351(k) Biosimilar | 6MG/0.6ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | September 1, 2022 | pegfilgrastim | Neulasta | Original | 2146 | 001 | CDER | |||||||||
|
|
CELLTRION, Inc. | 761404 | Stoboclo | denosumab-bmwo | 351(k) Interchangeable | 60MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | February 28, 2025 | October 29, 2025 | denosumab | Prolia | Original | 1996 | 001 | CDER | ||||||||
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Stratatech Corporation | 125730 | StrataGraft | Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat | 351(a) | 100CM SQUARED | Cell Sheets | Topical | Pouch | Disc | Voluntarily Revoked | June 15, 2021 | 0 | Original | 2144 | 001 | CBER | June 15, 2021 | June 15, 2033 | June 15, 2028 | |||||||
|
|
Alexion Pharmaceuticals, Inc. | 125513 | Strensiq | asfotase alfa | 351(a) | 18MG/0.45ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | October 23, 2015 | Original | 1743 | 001 | CDER | October 23, 2022 | ||||||||||
|
|
Alexion Pharmaceuticals, Inc. | 125513 | Strensiq | asfotase alfa | 351(a) | 28MG/0.7ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | October 23, 2015 | Original | 1743 | 002 | CDER | October 23, 2022 | ||||||||||
|
|
Alexion Pharmaceuticals, Inc. | 125513 | Strensiq | asfotase alfa | 351(a) | 40MG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | October 23, 2015 | Original | 1743 | 003 | CDER | October 23, 2022 | ||||||||||
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Alexion Pharmaceuticals, Inc. | 125513 | Strensiq | asfotase alfa | 351(a) | 80MG/0.8ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | October 23, 2015 | Original | 1743 | 004 | CDER | October 23, 2022 | ||||||||||
|
|
QOL Medical, LLC | 020772 | Sucraid | sacrosidase | 351(a) | 1,003,000IU/118ML (8,500IU/ML) | Solution For Oral | Oral | Bottle | Rx | Licensed | April 9, 1998 | Original | 2195 | 001 | CDER | April 9, 2005 | ||||||||||
|
|
QOL Medical, LLC | 020772 | Sucraid | sacrosidase | 351(a) | 17,000IU/2ML (8,500IU/ML) | Solution For Oral | Oral | Rx | Licensed | May 25, 2022 | 27 | Supplement | 2195 | 002 | CDER | April 9, 2005 | ||||||||||
|
|
AbbVie Inc. | 020032 | Survanta | beractant | 351(a) | 100MG/4ML (25MG/ML) | Suspension | Intratracheal | Single-Dose Vial | Rx | Licensed | July 1, 1991 | Original | 1889 | 001 | CDER | July 2, 1998 | ||||||||||
|
|
AbbVie Inc. | 020032 | Survanta | beractant | 351(a) | 200MG/8ML (25MG/ML) | Suspension | Intratracheal | Single-Dose Vial | Rx | Licensed | July 1, 1991 | Original | 1889 | 002 | CDER | July 2, 1998 | ||||||||||
|
|
Genentech, Inc. | 761197 | Susvimo | ranibizumab | 351(a) | 100MG/ML | Injection | Intravitreal | Single-Dose Vial | Rx | Licensed | October 22, 2021 | Original | 1048 | 001 | CDER | |||||||||||
|
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Merck Sharp & Dohme LLC | 103949 | Sylatron | peginterferon alfa-2b | 351(a) | 200MCG | For Injection | Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | March 29, 2011 | 5153 | Supplement | 0002 | 002 | CDER | ||||||||||
|
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Merck Sharp & Dohme LLC | 103949 | Sylatron | peginterferon alfa-2b | 351(a) | 300MCG | For Injection | Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | March 29, 2011 | 5153 | Supplement | 0002 | 003 | CDER | ||||||||||
|
|
Merck Sharp & Dohme LLC | 103949 | Sylatron | peginterferon alfa-2b | 351(a) | 600MCG | For Injection | Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | March 29, 2011 | 5153 | Supplement | 0002 | 004 | CDER | ||||||||||
|
|
Recordati Rare Diseases, Inc. | 125496 | Sylvant | siltuximab | 351(a) | 100MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 23, 2014 | Original | 1899 | 001 | CDER | April 23, 2021 | ||||||||||
|
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Recordati Rare Diseases, Inc. | 125496 | Sylvant | siltuximab | 351(a) | 400MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 23, 2014 | Original | 1899 | 002 | CDER | April 23, 2021 | ||||||||||
|
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Humacyte Global Inc. | 125812 | symvess | acellular tissue engineered vessel-tyod | 351(a) | 6 MM IN INNER DIAMETER,~42 CM LENGTH | Implant | Implantation | Tray & Lid | Rx | Licensed | December 19, 2024 | 0 | Original | 2336 | 001 | CBER | December 19, 2024 | December 19, 2036 | ||||||||
|
|
Swedish Orphan Biovitrum AB (publ) | 103770 | Synagis | palivizumab | 351(a) | 50MG | For Injection | Intramuscular | Single-Dose Vial | Disc | Licensed | June 19, 1998 | Original | 1859 | 001 | CDER | |||||||||||
|
|
Swedish Orphan Biovitrum AB (publ) | 103770 | Synagis | palivizumab | 351(a) | 100MG | For Injection | Intramuscular | Single-Dose Vial | Disc | Licensed | June 19, 1998 | Original | 1859 | 002 | CDER | |||||||||||
|
|
Swedish Orphan Biovitrum AB (publ) | 103770 | Synagis | palivizumab | 351(a) | 50MG/0.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | July 23, 2004 | 5059 | Supplement | 1859 | 003 | CDER | ||||||||||
|
|
Swedish Orphan Biovitrum AB (publ) | 103770 | Synagis | palivizumab | 351(a) | 100MG/1ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | July 23, 2004 | 5059 | Supplement | 1859 | 004 | CDER | ||||||||||
|
|
SmartPractice Denmark ApS | 103738 | T.R.U.E. Test | Thin-Layer Rapid Use Epicutaneous Patch Test | 351(a) | 36 MCG NICKEL/PATCH, 810 MCG WOOL ALCOHOL/PATCH, 486 MCG NEOMYCIN SULFATE/PATCH, 15.7 MCG CHROMIUM/PATCH, 510 MCG CAINE MIX/PATCH, 405 MCG FRAGRANCE MIX/PATCH, 972 MCG COLOPHONY/PATCH, 810 MCG PARABEN/PATCH, 648 MCG OF BALSAM OF PERU RESIN/PATCH, 18 MCG E | Patch | Topical | Pouch | Rx | Licensed | August 15, 1997 | 0 | Original | 1888 | 001 | CBER | ||||||||||
|
|
Corza Medical GmbH | 125351 | Tachosil | Fibrin Sealant Patch | 351(a) | 4.8 CM X 4.8 CM MG PER CM2 FOR FIBRINOGEN; IU PER CM2 FOR THROMBIN | Patch | Topical | Tray & Lid | Rx | Licensed | April 5, 2010 | 0 | Original | 2294 | 001 | CBER | ||||||||||
|
|
Corza Medical GmbH | 125351 | Tachosil | Fibrin Sealant Patch | 351(a) | 9.5 CM X 4.8 CM MG PER CM2 FOR FIBRINOGEN; IU PER CM2 FOR THROMBIN | Patch | Topical | Tray & Lid | Rx | Licensed | April 5, 2010 | 0 | Original | 2294 | 002 | CBER | ||||||||||
|
|
Corza Medical GmbH | 125351 | Tachosil | Fibrin Sealant Patch | 351(a) | 3.0 CM X 2.5 CM MG PER CM2 FOR FIBRINOGEN; IU PER CM2 FOR THROMBIN | Patch | Topical | Tray & Lid | Disc | Licensed | April 5, 2010 | 0 | Original | 2294 | 003 | CBER | ||||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 761090 | Takhzyro | lanadelumab-flyo | 351(a) | 300MG/2ML (150MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | August 23, 2018 | Original | 1898 | 001 | CDER | February 3, 2030 | ||||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 761090 | Takhzyro | lanadelumab-flyo | 351(a) | 300MG/2ML (150MG/ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | February 8, 2022 | 3 | Supplement | 1898 | 002 | CDER | February 3, 2030 | |||||||||
|
|
Takeda Pharmaceuticals U.S.A., Inc. | 761090 | Takhzyro | lanadelumab-flyo | 351(a) | 150MG/1ML (150MG/ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | February 3, 2023 | 10 | Supplement | 1898 | 003 | CDER | February 3, 2030 | |||||||||
|
|
Eli Lilly and Company | 125521 | Taltz | ixekizumab | 351(a) | 80MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | March 22, 2016 | Original | 1891 | 001 | CDER | |||||||||||
|
|
Eli Lilly and Company | 125521 | Taltz | ixekizumab | 351(a) | 80MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | March 22, 2016 | Original | 1891 | 002 | CDER | |||||||||||
|
|
Eli Lilly and Company | 125521 | Taltz | ixekizumab | 351(a) | 40MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | August 20, 2024 | 32 | Supplement | 1891 | 003 | CDER | ||||||||||
|
|
Eli Lilly and Company | 125521 | Taltz | ixekizumab | 351(a) | 20MG/0.25ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | August 20, 2024 | 32 | Supplement | 1891 | 004 | CDER | ||||||||||
|
|
Janssen Biotech, Inc. | 761342 | Talvey | talquetamab-tgvs | 351(a) | 40MG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | August 9, 2023 | Original | 1864 | 002 | CDER | August 9, 2030 | ||||||||||
|
|
Janssen Biotech, Inc. | 761342 | Talvey | talquetamab-tgvs | 351(a) | 3MG/1.5ML (2MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | August 9, 2023 | Original | 1864 | 001 | CDER | August 9, 2030 | ||||||||||
|
|
GlaxoSmithKline LLC | 125431 | Tanzeum | albiglutide | 351(a) | 30MG | For Injection | Subcutaneous | Autoinjector | Disc | Voluntarily Revoked | April 15, 2014 | Original | 1727 | 001 | CDER | |||||||||||
|
|
GlaxoSmithKline LLC | 125431 | Tanzeum | albiglutide | 351(a) | 50MG | For Injection | Subcutaneous | Autoinjector | Disc | Voluntarily Revoked | April 15, 2014 | Original | 1727 | 002 | CDER | |||||||||||
|
|
MassBiologics | 101322 | Tdvax | Tetanus and Diphtheria Toxoids Adsorbed | 351(a) | 0.5ML | Injection | Intramuscular | Single-Dose Vial | Disc | Licensed | July 27, 1970 | 0 | Original | 1779 | 001 | CBER | ||||||||||
|
|
Kite Pharma, Inc. | 125703 | Tecartus | Brexucabtagene Autoleucel | 351(a) | 2×10^6 CAR-positive viable T cells per kg body weight | For Injection | Intravenous | Bag | Rx | Licensed | July 24, 2020 | 0 | Original | 2064 | 001 | CBER | October 1, 2028 | |||||||||
|
|
USWM CT, LLC | 125789 | tecelra | afamitresgene autoleucel | 351(a) | 2.68 x 10^9 to 10 x 10^9 CELL/ML | Suspension | Intravenous | Bag | Rx | Licensed | August 1, 2024 | 0 | Original | 2416 | 001 | CBER | August 1, 2024 | August 1, 2036 | August 1, 2031 | |||||||
|
|
Genentech, Inc. | 761034 | Tecentriq | atezolizumab | 351(a) | 1,200MG/20ML (60MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 18, 2016 | Original | 1048 | 001 | CDER | December 9, 2029 | ||||||||||
|
|
Genentech, Inc. | 761034 | Tecentriq | atezolizumab | 351(a) | 840MG/14ML (60MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 8, 2019 | 18 | Supplement | 1048 | 002 | CDER | December 9, 2029 | |||||||||
|
|
Genentech, Inc. | 761347 | Tecentriq Hybreza | atezolizumab and hyaluronidase-tqjs | 351(a) | 1,875MG/15ML; 30,000UNITS/15ML (125MG/2,000UNITS/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | September 12, 2024 | Original | 1048 | 001 | CDER | |||||||||||
|
|
Janssen Biotech, Inc. | 761291 | Tecvayli | teclistamab-cqyv | 351(a) | 30MG/3ML (10MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | October 25, 2022 | Original | 1864 | 001 | CDER | October 25, 2029 | ||||||||||
|
|
Janssen Biotech, Inc. | 761291 | Tecvayli | teclistamab-cqyv | 351(a) | 153MG/1.7ML (90MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | October 25, 2022 | Original | 1864 | 002 | CDER | October 25, 2029 | ||||||||||
|
|
Sanofi Pasteur Limited | 103171 | Tenivac | Tetanus and Diphtheria Toxoids Adsorbed | 351(a) | 5LF,2LF/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | November 3, 2003 | 0 | Original | 1726 | 001 | CBER | ||||||||||
|
|
Sanofi Pasteur Limited | 103171 | Tenivac | Tetanus and Diphtheria Toxoids Adsorbed | 351(a) | 5LF,2LF/.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | November 3, 2003 | 0 | Original | 1726 | 002 | CBER | ||||||||||
|
|
Horizon Therapeutics Ireland DAC | 761143 | Tepezza | teprotumumab-trbw | 351(a) | 500MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | January 21, 2020 | Original | 2022 | 001 | CDER | January 21, 2027 | ||||||||||
|
|
BeiGene USA, Inc. | 761232 | Tevimbra | tislelizumab-jsgr | 351(a) | 100MG/10ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 13, 2024 | Original | 2232 | 001 | CDER | March 13, 2031 | ||||||||||
|
|
AstraZeneca AB | 761224 | Tezspire | tezepelumab-ekko | 351(a) | 210MG/1.91ML (110MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | December 17, 2021 | Original | 2059 | 001 | CDER | |||||||||||
|
|
AstraZeneca AB | 761224 | Tezspire | tezepelumab-ekko | 351(a) | 210MG/1.91ML (110MG/ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | December 17, 2021 | Original | 2059 | 002 | CDER | |||||||||||
|
|
AstraZeneca AB | 761224 | Tezspire | tezepelumab-ekko | 351(a) | 210MG/1.91ML (110MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | February 1, 2023 | 1 | Supplement | 2059 | 003 | CDER | ||||||||||
|
|
Sanofi Pasteur Limited | 103943 | TheraCys | BCG Live | 351(a) | 81MG | For Injection | Intravesical | Vial | Rx | Voluntarily Revoked | February 24, 2000 | 0 | Original | 1726 | 001 | CBER | ||||||||||
|
|
Grifols Therapeutics LLC | 103196 | Thrombate Iii | Antithrombin III (Human) | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 30, 1991 | 0 | Original | 1871 | 001 | CBER | December 30, 1998 | |||||||||
|
|
GenTrac, Inc. | 102865 | Thrombin-Jmi, Thrombocoll | Thrombin, Topical (Bovine) | 351(a) | 20,000IU | Powder | Topical | Vial | Rx | Licensed | February 3, 1986 | 0 | Original | 0977 | 001 | CBER | ||||||||||
|
|
GenTrac, Inc. | 102865 | Thrombin-Jmi, Thrombocoll | Thrombin, Topical (Bovine) | 351(a) | 5,000IU | Powder | Topical | Vial | Rx | Licensed | February 10, 2011 | 5387 | Supplement | 0977 | 002 | CBER | ||||||||||
|
|
Genzyme Corporation | 103869 | Thymoglobulin | Anti-thymocyte Globulin (Rabbit) | 351(a) | 25MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 19, 1999 | 0 | Original | 1596 | 001 | CBER | ||||||||||
|
|
Genzyme Corporation | 020898 | Thyrogen | thyrotropin alfa | 351(a) | 0.9MG | For Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | November 30, 1998 | Original | 1596 | 001 | CDER | December 14, 2014 | ||||||||||
|
|
Merck Teknika LLC | 102821 | Tice Bcg | BCG Live | 351(a) | 100-800 MIL CFU | For Injection | Intravesical | Single-Dose Vial | Rx | Licensed | June 21, 1989 | 0 | Original | 1747 | 001 | CBER | ||||||||||
|
|
Pfizer Ireland Pharmaceuticals Unlimited Company | 125740 | Ticovac | Tick-Borne Encephalitis Vaccine | 351(a) | 2.4UG/0.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | August 13, 2021 | 0 | Original | 2060 | 001 | CBER | ||||||||||
|
|
Pfizer Ireland Pharmaceuticals Unlimited Company | 125740 | Ticovac | Tick-Borne Encephalitis Vaccine | 351(a) | 1.2UG/0.25ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | August 13, 2021 | 0 | Original | 2060 | 002 | CBER | ||||||||||
|
|
Baxter Healthcare Corporation | 103980 | Tisseel | Fibrin Sealant (Tisseel) | 351(a) | 86.5 MG/ML Fibrinogen; 3000 KIU/ML Fibrinolysis Inh; 500 U/ML Thrombin | For Solution | Topical | Single-Dose Vial | Rx | Licensed | May 1, 1998 | 0 | Original | 0140 | 001 | CBER | ||||||||||
|
|
Baxter Healthcare Corporation | 103980 | Tisseel | Fibrin Sealant (Tisseel) | 351(a) | 86.5 MG/ML Fibrinogen; 3000 KIU/ML Fibrinolysis Inh; 500 U/ML Thrombin | Solution | Topical | Pre-Filled Syringe | Rx | Licensed | July 27, 2006 | 5121 | Supplement | 0140 | 002 | CBER | ||||||||||
|
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Seagen Inc. | 761208 | Tivdak | tisotumab vedotin-tftv | 351(a) | 40MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | September 20, 2021 | Original | 2257 | 001 | CDER | |||||||||||
|
|
Genentech, Inc. | 103909 | TNKase | tenecteplase | 351(a) | 50MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 2, 2000 | Original | 1048 | 001 | CDER | |||||||||||
|
|
Genentech, Inc. | 103909 | TNKase | tenecteplase | 351(a) | 25MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 28, 2025 | 5197 | Supplement | 1048 | 002 | CDER | ||||||||||
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Biogen MA Inc. | 761354 | Tofidence | tocilizumab-bavi | 351(k) Biosimilar | 80MG/4ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | September 29, 2023 | tocilizumab | Actemra | Original | 2344 | 001 | CDER | |||||||||
|
|
Biogen MA Inc. | 761354 | Tofidence | tocilizumab-bavi | 351(k) Biosimilar | 200MG/10ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | September 29, 2023 | tocilizumab | Actemra | Original | 2344 | 002 | CDER | |||||||||
|
|
Biogen MA Inc. | 761354 | Tofidence | tocilizumab-bavi | 351(k) Biosimilar | 400MG/20ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | September 29, 2023 | tocilizumab | Actemra | Original | 2344 | 003 | CDER | |||||||||
|
|
Sanofi-Aventis U.S. LLC | 206538 | Toujeo | insulin glargine | 351(a) | 450UNITS/1.5ML (300UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | February 25, 2015 | Original | 1752 | 001 | CDER | |||||||||||
|
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Sanofi-Aventis U.S. LLC | 206538 | Toujeo | insulin glargine | 351(a) | 900UNITS/3ML (300UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | March 26, 2018 | 6 | Supplement | 1752 | 002 | CDER | ||||||||||
|
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Bayer HealthCare Pharmaceuticals Inc. | 020304 | Trasylol | aprotinin | 351(a) | 1,000,000KIU/100ML (10,000KIU/ML) | Injection | Intravenous | Single-Dose Vial | Disc | Licensed | December 29, 1993 | Original | 1778 | 001 | CDER | December 29, 2000 | ||||||||||
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Bayer HealthCare Pharmaceuticals Inc. | 020304 | Trasylol | aprotinin | 351(a) | 2,000,000KIU/200ML (10,000KIU/ML) | Injection | Intravenous | Single-Dose Vial | Disc | Licensed | December 29, 1993 | Original | 1778 | 002 | CDER | December 29, 2000 | ||||||||||
|
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Pfizer Ireland Pharmaceuticals | 761081 | Trazimera | trastuzumab-qyyp | 351(k) Biosimilar | 420MG | For Injection | Intravenous | Multi-Dose Vial | Rx | Licensed | March 11, 2019 | trastuzumab | Herceptin | Original | 2060 | 001 | CDER | |||||||||
|
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Pfizer Ireland Pharmaceuticals | 761081 | Trazimera | trastuzumab-qyyp | 351(k) Biosimilar | 150MG | For Injection | Intravenous | Multi-Dose Vial | Rx | Licensed | November 30, 2020 | trastuzumab | Herceptin | 8 | Supplement | 2060 | 002 | CDER | ||||||||
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Janssen Biotech, Inc. | 761061 | Tremfya | guselkumab | 351(a) | 100MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | July 13, 2017 | Original | 1864 | 001 | CDER | |||||||||||
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Janssen Biotech, Inc. | 761061 | Tremfya | guselkumab | 351(a) | 100MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | January 28, 2019 | 1 | Supplement | 1864 | 002 | CDER | ||||||||||
|
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Janssen Biotech, Inc. | 761061 | Tremfya | guselkumab | 351(a) | 200MG/2ML (100MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | September 11, 2024 | 21 | Supplement | 1864 | 003 | CDER | ||||||||||
|
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Janssen Biotech, Inc. | 761061 | Tremfya | guselkumab | 351(a) | 200MG/2ML (100MG/ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | September 11, 2024 | 21 | Supplement | 1864 | 004 | CDER | ||||||||||
|
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Janssen Biotech, Inc. | 761061 | Tremfya | guselkumab | 351(a) | 200MG/20ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | September 11, 2024 | 21 | Supplement | 1864 | 005 | CDER | ||||||||||
|
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Janssen Biotech, Inc. | 761061 | Tremfya | guselkumab | 351(a) | 100MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | March 25, 2025 | 27 | Supplement | 1864 | 006 | CDER | ||||||||||
|
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Novo Nordisk Inc. | 203314 | Tresiba | insulin degludec | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | September 25, 2015 | Original | 1261 | 001 | CDER | |||||||||||
|
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Novo Nordisk Inc. | 203314 | Tresiba | insulin degludec | 351(a) | 600UNITS/3ML (200UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | September 25, 2015 | Original | 1261 | 002 | CDER | |||||||||||
|
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Novo Nordisk Inc. | 203314 | Tresiba | insulin degludec | 351(a) | 1,000UNITS/10ML (100UNITS/ML) | Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | November 21, 2018 | 10 | Supplement | 1261 | 003 | CDER | ||||||||||
|
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Novo Nordisk Inc. | 125398 | Tretten | Coagulation Factor XIII A-Subunit (Recombinant) | 351(a) | 2000 - 3125IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 23, 2013 | 0 | Original | 1261 | 001 | CBER | December 23, 2020 | |||||||||
|
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Sanofi Pasteur Inc. | 103922 | Tripedia | Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed | 351(a) | 6.7LF, 5LF, 46.8UG/.5ML | Injection | Intramuscular | Vial | Rx | Voluntarily Revoked | December 9, 1999 | 0 | Original | 1725 | 001 | CBER | ||||||||||
|
|
Gilead Sciences, Inc. | 761115 | Trodelvy | sacituzumab govitecan-hziy | 351(a) | 180MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 22, 2020 | Original | 2258 | 001 | CDER | |||||||||||
|
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Theratechnologies Inc. | 761065 | Trogarzo | ibalizumab-uiyk | 351(a) | 200MG/1.33ML (150MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 6, 2018 | Original | 2091 | 001 | CDER | March 6, 2025 | ||||||||||
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Eli Lilly and Company | 125469 | Trulicity | dulaglutide | 351(a) | 0.75MG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | September 18, 2014 | Original | 1891 | 001 | CDER | |||||||||||
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Eli Lilly and Company | 125469 | Trulicity | dulaglutide | 351(a) | 1.5MG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | September 18, 2014 | Original | 1891 | 002 | CDER | |||||||||||
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Eli Lilly and Company | 125469 | Trulicity | dulaglutide | 351(a) | 0.75MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | September 18, 2014 | Original | 1891 | 003 | CDER | |||||||||||
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Eli Lilly and Company | 125469 | Trulicity | dulaglutide | 351(a) | 1.5MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Licensed | September 18, 2014 | Original | 1891 | 004 | CDER | |||||||||||
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Eli Lilly and Company | 125469 | Trulicity | dulaglutide | 351(a) | 3MG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | September 4, 2020 | 36 | Supplement | 1891 | 005 | CDER | ||||||||||
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Eli Lilly and Company | 125469 | Trulicity | dulaglutide | 351(a) | 4.5MG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | September 4, 2020 | 36 | Supplement | 1891 | 006 | CDER | ||||||||||
|
|
Wyeth Pharmaceuticals LLC | 125549 | Trumenba | Meningococcal Group B Vaccine | 351(a) | 0.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | October 29, 2014 | 0 | Original | 0003 | 001 | CBER | October 29, 2014 | October 29, 2026 | ||||||||
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CELLTRION, Inc. | 761088 | Truxima | rituximab-abbs | 351(k) Biosimilar | 100MG/10ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 28, 2018 | rituximab | Rituxan | Original | 1996 | 001 | CDER | |||||||||
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CELLTRION, Inc. | 761088 | Truxima | rituximab-abbs | 351(k) Biosimilar | 500MG/50ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 28, 2018 | rituximab | Rituxan | Original | 1996 | 002 | CDER | |||||||||
|
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Sanofi Pasteur Limited | 103941 | Tubersol | Tuberculin, Purified Protein Derivative | 351(a) | 5TU/.1ML | Injection | Intradermal | Multi-Dose Vial | Rx | Licensed | February 24, 2000 | 0 | Original | 1726 | 001 | CBER | ||||||||||
|
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GlaxoSmithKline Biologicals | 103850 | Twinrix | Hepatitis A & Hepatitis B (Recombinant) Vaccine | 351(a) | 1ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | May 11, 2001 | 0 | Original | 1617 | 001 | CBER | ||||||||||
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Fresenius Kabi USA, LLC | 761275 | Tyenne | tocilizumab-aazg | 351(k) Biosimilar | 80MG/4ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 5, 2024 | tocilizumab | Actemra | Original | 2146 | 001 | CDER | |||||||||
|
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Fresenius Kabi USA, LLC | 761275 | Tyenne | tocilizumab-aazg | 351(k) Biosimilar | 200MG/10ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 5, 2024 | tocilizumab | Actemra | Original | 2146 | 002 | CDER | |||||||||
|
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Fresenius Kabi USA, LLC | 761275 | Tyenne | tocilizumab-aazg | 351(k) Biosimilar | 400MG/20ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 5, 2024 | tocilizumab | Actemra | Original | 2146 | 003 | CDER | |||||||||
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Fresenius Kabi USA, LLC | 761449 | Tyenne | tocilizumab-aazg | 351(k) Biosimilar | 162MG/0.9ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | March 14, 2025 | tocilizumab | Actemra | Original | 2146 | 001 | CDER | |||||||||
|
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Fresenius Kabi USA, LLC | 761449 | Tyenne | tocilizumab-aazg | 351(k) Biosimilar | 162MG/0.9ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | March 14, 2025 | tocilizumab | Actemra | Original | 2146 | 002 | CDER | |||||||||
|
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Sanofi Winthrop Industrie | 103936 | Typhim Vi | Typhoid Vi Polysaccharide Vaccine | 351(a) | 50UG/ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | February 4, 2000 | 0 | Original | 1724 | 001 | CBER | ||||||||||
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Sanofi Winthrop Industrie | 103936 | Typhim Vi | Typhoid Vi Polysaccharide Vaccine | 351(a) | 25UG/.5ML | Injection | Intramuscular | Multi-Dose Vial | Rx | Licensed | February 4, 2000 | 0 | Original | 1724 | 002 | CBER | ||||||||||
|
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Sandoz Inc. | 761322 | Tyruko | natalizumab-sztn | 351(k) Biosimilar | 300MG/15ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 24, 2023 | natalizumab | Tysabri | Original | 2003 | 001 | CDER | |||||||||
|
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Biogen Inc. | 125104 | Tysabri | natalizumab | 351(a) | 300MG/15ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 23, 2004 | Original | 1697 | 001 | CDER | Yes | ||||||||||
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Provention Bio, Inc. | 761183 | Tzield | teplizumab-mzwv | 351(a) | 2MG/2ML (1MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 17, 2022 | Original | 2170 | 001 | CDER | |||||||||||
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Accord BioPharma Inc. | 761039 | Udenyca | pegfilgrastim-cbqv | 351(k) Biosimilar | 6MG/0.6ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | March 3, 2023 | pegfilgrastim | Neulasta | 13 | Supplement | 2105 | 002 | CDER | ||||||||
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Accord BioPharma Inc. | 761039 | Udenyca | pegfilgrastim-cbqv | 351(k) Biosimilar | 6MG/0.6ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | November 2, 2018 | pegfilgrastim | Neulasta | Original | 2105 | 001 | CDER | |||||||||
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Accord BioPharma Inc. | 761039 | Udenyca Onbody | pegfilgrastim-cbqv | 351(k) Biosimilar | 6MG/0.6ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | December 22, 2023 | pegfilgrastim | Neulasta | 15 | Supplement | 2105 | 003 | CDER | ||||||||
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Alexion Pharmaceuticals, Inc. | 761108 | Ultomiris | ravulizumab-cwvz | 351(a) | 300MG/30ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 21, 2018 | Original | 1743 | 001 | CDER | June 7, 2028 | ||||||||||
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Alexion Pharmaceuticals, Inc. | 761108 | Ultomiris | ravulizumab-cwvz | 351(a) | 300MG/3ML (100MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 9, 2020 | 5 | Supplement | 1743 | 002 | CDER | June 7, 2028 | |||||||||
|
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Alexion Pharmaceuticals, Inc. | 761108 | Ultomiris | ravulizumab-cwvz | 351(a) | 1,100MG/11ML (100MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 9, 2020 | 5 | Supplement | 1743 | 003 | CDER | June 7, 2028 | |||||||||
|
|
Alexion Pharmaceuticals, Inc. | 761108 | Ultomiris | ravulizumab-cwvz | 351(a) | 245MG/3.5ML (70MG/ML) | Injection | Subcutaneous | Single-Dose Cartridge | Rx | Licensed | June 22, 2022 | 21 | Supplement | 1743 | 004 | CDER | June 7, 2028 | |||||||||
|
|
United Therapeutics Corporation | 125516 | Unituxin | dinutuximab | 351(a) | 17.5MG/5ML (3.5MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 10, 2015 | Original | 1993 | 001 | CDER | March 10, 2022 | ||||||||||
|
|
Checkpoint Therapeutics, Inc. | 761297 | Unloxcyt | cosibelimab-ipdl | 351(a) | 300MG/5ML (60MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 13, 2024 | Original | 2275 | 001 | CDER | |||||||||||
|
|
Horizon Therapeutics Ireland DAC | 761142 | Uplizna | inebilizumab-cdon | 351(a) | 100MG/10ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 11, 2020 | Original | 2022 | 001 | CDER | June 11, 2027 | ||||||||||
|
|
Genentech, Inc. | 761235 | Vabysmo | faricimab-svoa | 351(a) | 6MG/0.05ML (120MG/ML) | Injection | Intravitreal | Single-Dose Vial | Rx | Licensed | January 28, 2022 | Original | 1048 | 001 | CDER | |||||||||||
|
|
Genentech, Inc. | 761235 | Vabysmo | faricimab-svoa | 351(a) | 6MG/0.05ML (120MG/ML) | Injection | Intravitreal | Pre-Filled Syringe | Rx | Licensed | July 9, 2024 | 5 | Supplement | 1048 | 002 | CDER | ||||||||||
|
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Merck Sharp & Dohme LLC | 103606 | Vaqta | Hepatitis A Vaccine Inactivated | 351(a) | 50U/ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | March 29, 1996 | 0 | Original | 0002 | 001 | CBER | ||||||||||
|
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Merck Sharp & Dohme LLC | 103606 | Vaqta | Hepatitis A Vaccine Inactivated | 351(a) | 25U/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | March 29, 1996 | 0 | Original | 0002 | 002 | CBER | ||||||||||
|
|
Merck Sharp & Dohme LLC | 103606 | Vaqta | Hepatitis A Vaccine Inactivated | 351(a) | 50U/ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | March 29, 1996 | 0 | Original | 0002 | 003 | CBER | ||||||||||
|
|
Merck Sharp & Dohme LLC | 103606 | Vaqta | Hepatitis A Vaccine Inactivated | 351(a) | 25U/.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | March 29, 1996 | 0 | Original | 0002 | 004 | CBER | ||||||||||
|
|
Merck Sharp & Dohme LLC | 103552 | Varivax | Varicella Virus Vaccine Live | 351(a) | NLT 1350PFU/.5ML | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | March 17, 1995 | 0 | Original | 0002 | 001 | CBER | ||||||||||
|
|
Merck Sharp & Dohme LLC | 103552 | Varivax | Varicella Virus Vaccine Live | 351(a) | NLT 1350PFU/.5ML | For Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | February 27, 2023 | 6277 | Supplement | 0002 | 002 | CBER | ||||||||||
|
|
Kamada Ltd. | 125430 | Varizig | Varicella Zoster Immune Globulin (Human) | 351(a) | 125IU | For Injection | Intramuscular | Vial | Disc | Licensed | December 20, 2012 | 0 | Original | 2098 | 001 | CBER | December 20, 2019 | |||||||||
|
|
Kamada Ltd. | 125430 | Varizig | Varicella Zoster Immune Globulin (Human) | 351(a) | 125IU | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | September 29, 2014 | 27 | Supplement | 2098 | 002 | CBER | December 20, 2019 | |||||||||
|
|
Bavarian Nordic A/S | 125597 | Vaxchora | Cholera Vaccine, Live, Oral | 351(a) | 100ML | Suspension | Oral | Packet | Rx | Licensed | June 10, 2016 | 0 | Original | 2096 | 001 | CBER | ||||||||||
|
|
Bavarian Nordic A/S | 125597 | Vaxchora | Cholera Vaccine, Live, Oral | 351(a) | 50ML | Suspension | Oral | Packet | Rx | Licensed | December 23, 2020 | 123 | Supplement | 2096 | 002 | CBER | ||||||||||
|
|
Bavarian Nordic A/S | 125597 | Vaxchora | Cholera Vaccine, Live, Oral | 351(a) | 100ML | Suspension | Oral | Packet | Rx | Licensed | December 23, 2020 | 123 | Supplement | 2096 | 003 | CBER | ||||||||||
|
|
MSP Vaccine Company | 125563 | Vaxelis | Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine | 351(a) | 0.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | December 21, 2018 | 0 | Original | 2007 | 001 | CBER | ||||||||||
|
|
MSP Vaccine Company | 125563 | Vaxelis | Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine | 351(a) | 0.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | September 25, 2020 | 34 | Supplement | 2007 | 002 | CBER | ||||||||||
|
|
Merck Sharp & Dohme LLC | 125741 | Vaxneuvance | Pneumococcal 15-valent Conjugate Vaccine | 351(a) | 2.0UG | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | July 16, 2021 | 0 | Original | 0002 | 001 | CBER | July 16, 2021 | July 16, 2033 | ||||||||
|
|
Amgen Inc. | 125147 | Vectibix | panitumumab | 351(a) | 100MG/5ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | September 27, 2006 | Original | 1080 | 001 | CDER | |||||||||||
|
|
Amgen Inc. | 125147 | Vectibix | panitumumab | 351(a) | 400MG/20ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | September 27, 2006 | Original | 1080 | 002 | CDER | |||||||||||
|
|
Amgen Inc. | 125147 | Vectibix | panitumumab | 351(a) | 200MG/10ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Disc | Licensed | September 27, 2006 | Original | 1080 | 003 | CDER | |||||||||||
|
|
CELLTRION, Inc. | 761268 | Vegzelma | bevacizumab-adcd | 351(k) Biosimilar | 100MG/4ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | September 27, 2022 | bevacizumab | Avastin | Original | 1996 | 001 | CDER | |||||||||
|
|
CELLTRION, Inc. | 761268 | Vegzelma | bevacizumab-adcd | 351(k) Biosimilar | 400MG/16ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | September 27, 2022 | bevacizumab | Avastin | Original | 1996 | 002 | CDER | |||||||||
|
|
Regeneron Pharmaceuticals, Inc. | 761339 | Veopoz | pozelimab-bbfg | 351(a) | 400MG/2ML (200MG/ML) | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | August 18, 2023 | Original | 1760 | 001 | CDER | August 18, 2030 | ||||||||||
|
|
Boehringer Ingelheim Pharma GmbH & Co. KG | 103769 | Verluma | nofetumomab | 351(a) | 10MG/ML | Injection | Intravenous | Disc | Voluntarily Revoked | October 13, 1998 | 1251 | 001 | CDER | |||||||||||||
|
|
BioMarin Pharmaceutical Inc. | 125460 | Vimizim | elosulfase alfa | 351(a) | 5MG/5ML (1MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 14, 2014 | Original | 1649 | 001 | CDER | February 14, 2021 | ||||||||||
|
|
Bavarian Nordic A/S | 125820 | VIMKUNYA | Chikungunya Vaccine, Recombinant | 351(a) | 40UG/0.8ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | February 14, 2025 | 0 | Original | 2096 | 001 | CBER | February 14, 2025 | February 14, 2037 | ||||||||
|
|
Viokace, LLC | 022542 | Viokace | pancrelipase | 351(a) | 10,440USP UNITS; 39,150USP UNITS; 39,150USP UNITS | Tablet | Oral | Rx | Licensed | March 1, 2012 | Original | 2196 | 001 | CDER | ||||||||||||
|
|
Viokace, LLC | 022542 | Viokace | pancrelipase | 351(a) | 20,880USP UNITS; 78,300USP UNITS; 78,300USP UNITS | Tablet | Oral | Rx | Licensed | March 1, 2012 | Original | 2196 | 002 | CDER | ||||||||||||
|
|
Instituto Grifols, S.A. | 125640 | Vistaseal | Fibrin Sealant (Human) | 351(a) | 10ML | Frozen | Topical | Pre-Filled Syringe | Rx | Licensed | November 1, 2017 | 0 | Original | 1181 | 001 | CBER | ||||||||||
|
|
Instituto Grifols, S.A. | 125640 | Vistaseal | Fibrin Sealant (Human) | 351(a) | 2ML | Frozen | Topical | Pre-Filled Syringe | Rx | Licensed | November 1, 2017 | 0 | Original | 1181 | 002 | CBER | ||||||||||
|
|
Instituto Grifols, S.A. | 125640 | Vistaseal | Fibrin Sealant (Human) | 351(a) | 4ML | Frozen | Topical | Pre-Filled Syringe | Rx | Licensed | November 1, 2017 | 0 | Original | 1181 | 003 | CBER | ||||||||||
|
|
Instituto Grifols, S.A. | 125640 | Vistaseal | Fibrin Sealant (Human) | 351(a) | 6ML | Frozen | Topical | Pre-Filled Syringe | Rx | Licensed | November 1, 2017 | 0 | Original | 1181 | 004 | CBER | ||||||||||
|
|
Bausch & Lomb Incorporated | 021640 | Vitrase | hyaluronidase | 351(a) | 6,200UNITS/ML | Injection | Infiltration, Interstitial, Intramuscular, Intraocular, Peribulbar, Retrobulbar, Soft Tissue, Subcutaneous | Single-Dose Vial | Disc | Licensed | May 5, 2004 | Original | 2180 | 001 | CDER | |||||||||||
|
|
Bausch & Lomb Incorporated | 021640 | Vitrase | hyaluronidase | 351(a) | 200UNITS/ML | Injection | Infiltration, Interstitial, Intramuscular, Intraocular, Peribulbar, Retrobulbar, Soft Tissue, Subcutaneous | Single-Dose Vial | Rx | Licensed | December 2, 2004 | 3 | Supplement | 2180 | 002 | CDER | ||||||||||
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|
CSL Behring GmbH | 125115 | Vivaglobin | Immune Globulin Subcutaneous (Human) | 351(a) | 160MG/ML | For Injection | Subcutaneous | Vial | Disc | Voluntarily Revoked | January 9, 2006 | 0 | Original | 1765 | 001 | CBER | ||||||||||
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Bavarian Nordic A/S | 103123 | Vivotif | Typhoid Vaccine Live Oral Ty21a | 351(a) | 2-6.8 BIL. CFU | Capsule | Oral | Blister Pack | Rx | Licensed | December 15, 1989 | 0 | Original | 2096 | 001 | CBER | ||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 125577 | Vonvendi | von Willebrand factor (Recombinant) | 351(a) | 1300IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 8, 2015 | 0 | Original | 1898 | 001 | CBER | January 28, 2029 | |||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 125577 | Vonvendi | von Willebrand factor (Recombinant) | 351(a) | 650IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 8, 2015 | 0 | Original | 1898 | 002 | CBER | January 28, 2029 | |||||||||
|
|
BTG International Inc. | 125327 | Voraxaze | glucarpidase | 351(a) | 1,000UNITS | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | January 17, 2012 | Original | 1861 | 001 | CDER | January 17, 2019 | ||||||||||
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Aimmune Therapeutics, Inc. | 125757 | Vowst | fecal microbiota spores, live-brpk | 351(a) | 1X10 LOG 6 AND 3X10 LOG 7CFU/TAB | Capsule | Oral | Bottle | Rx | Licensed | April 26, 2023 | 0 | Original | 2109 | 001 | CBER | April 26, 2023 | April 26, 2035 | April 26, 2030 | |||||||
|
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Otsuka Pharmaceutical Company, Ltd. | 761434 | Voyxact | sibeprenlimab-szsi | 351(a) | 400MG/2ML (200MG/ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | November 25, 2025 | Original | 2387 | 001 | CDER | |||||||||||
|
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Takeda Pharmaceuticals U.S.A., Inc. | 022575 | VPRIV | velaglucerase alfa | 351(a) | 400UNITS | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 26, 2010 | Original | 1898 | 001 | CDER | |||||||||||
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Takeda Pharmaceuticals U.S.A., Inc. | 022575 | VPRIV | velaglucerase alfa | 351(a) | 200UNITS | For Injection | Intravenous | Single-Dose Vial | Disc | Licensed | February 26, 2010 | Original | 1898 | 002 | CDER | |||||||||||
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Lundbeck Seattle BioPharmaceuticals, Inc. | 761119 | Vyepti | eptinezumab-jjmr | 351(a) | 100MG/ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 21, 2020 | Original | 2097 | 001 | CDER | |||||||||||
|
|
Krystal Biotech, Inc. | 125774 | VYJUVEK | beremagene geperpavec-svdt | 351(a) | 5.0x10^9 PFU/mL | Gel | Topical | Single-Dose Vial | Rx | Licensed | May 19, 2023 | 0 | Original | 2301 | 001 | CBER | May 19, 2030 | |||||||||
|
|
Astellas Pharma US, Inc. | 761365 | Vyloy | zolbetuximab-clzb | 351(a) | 100MG | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 18, 2024 | Original | 2124 | 001 | CDER | October 18, 2031 | ||||||||||
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|
Astellas Pharma US, Inc. | 761365 | Vyloy | zolbetuximab-clzb | 351(a) | 300MG | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 24, 2025 | 2 | Supplement | 2124 | 002 | CDER | October 18, 2031 | |||||||||
|
|
Argenx BV | 761195 | Vyvgart | efgartigimod alfa-fcab | 351(a) | 400MG/20ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 17, 2021 | Original | 2217 | 001 | CDER | December 17, 2028 | ||||||||||
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|
Argenx BV | 761304 | Vyvgart Hytrulo | efgartigimod alfa and hyaluronidase-qvfc | 351(a) | 1,008MG/5.6ML; 11,200UNITS/5.6ML (180MG/2,000UNITS/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | June 20, 2023 | Original | 2217 | 001 | CDER | June 21, 2031 | ||||||||||
|
|
Argenx BV | 761304 | Vyvgart Hytrulo | efgartigimod alfa and hyaluronidase-qvfc | 351(a) | 1,000MG/5ML;10,000UNITS/5ML (200MG/2,000UNITS/ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | April 10, 2025 | 8 | Supplement | 2217 | 002 | CDER | June 21, 2031 | |||||||||
|
|
Fondazione Telethon Ets | 125846 | waskyra | etuvetidigene autotemcel | 351(a) | 1.9-11.4x10^6CD34+ CELLS/ML | Solution | Intravenous | Bag | Rx | Licensed | December 9, 2025 | 0 | Original | 2378 | 001 | CBER | ||||||||||
|
|
Amgen Inc. | 761285 | Wezlana | ustekinumab-auub | 351(k) Interchangeable | 45MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | October 31, 2023 | October 31, 2023 | ustekinumab | Stelara | Original | 1080 | 001 | CDER | 45777 | |||||||
|
|
Amgen Inc. | 761285 | Wezlana | ustekinumab-auub | 351(k) Interchangeable | 90MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | October 31, 2023 | October 31, 2023 | ustekinumab | Stelara | Original | 1080 | 002 | CDER | 45777 | |||||||
|
|
Amgen Inc. | 761285 | Wezlana | ustekinumab-auub | 351(k) Interchangeable | 45MG/0.5ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | October 31, 2023 | October 31, 2023 | ustekinumab | Stelara | Original | 1080 | 003 | CDER | 45777 | |||||||
|
|
Amgen Inc. | 761331 | Wezlana | ustekinumab-auub | 351(k) Interchangeable | 130MG/26ML (5MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 31, 2023 | October 31, 2023 | ustekinumab | Stelara | Original | 1080 | 001 | CDER | 45777 | |||||||
|
|
Amgen Inc. | 761285 | Wezlana | ustekinumab-auub | 351(k) Biosimilar | 45MG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | December 26, 2024 | ustekinumab | Stelara | 1 | Supplement | 1080 | 004 | CDER | ||||||||
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|
Amgen Inc. | 761285 | Wezlana | ustekinumab-auub | 351(k) Biosimilar | 90MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | December 26, 2024 | ustekinumab | Stelara | 1 | Supplement | 1080 | 005 | CDER | ||||||||
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|
Octapharma Pharmazeutika Produktionsges.m.b.H. | 125251 | Wilate | von Willebrand Factor/Coagulation Factor VIII Complex (Human) | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 20, 2010 | 22 | Supplement | 1646 | 001 | CBER | December 1, 2030 | |||||||||
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Octapharma Pharmazeutika Produktionsges.m.b.H. | 125251 | Wilate | von Willebrand Factor/Coagulation Factor VIII Complex (Human) | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 20, 2010 | 22 | Supplement | 1646 | 002 | CBER | December 1, 2030 | |||||||||
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|
Merck Sharp & Dohme LLC | 761363 | Winrevair | sotatercept-csrk | 351(a) | 45MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | March 26, 2024 | Original | 0002 | 001 | CDER | March 26, 2031 | ||||||||||
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|
Merck Sharp & Dohme LLC | 761363 | Winrevair | sotatercept-csrk | 351(a) | 60MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | March 26, 2024 | Original | 0002 | 002 | CDER | March 26, 2031 | ||||||||||
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Kamada Ltd. | 103649 | Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized | Rho(D) Immune Globulin Intravenous (Human) | 351(a) | 5000IU | For Injection | Intramuscular | Vial | Disc | Licensed | April 2, 1996 | 0 | Original | 2098 | 001 | CBER | March 24, 2002 | |||||||||
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Kamada Ltd. | 103649 | Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized | Rho(D) Immune Globulin Intravenous (Human) | 351(a) | 5000IU | For Injection | Intravenous | Vial | Disc | Licensed | April 2, 1996 | 0 | Original | 2098 | 002 | CBER | March 24, 2002 | |||||||||
|
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Kamada Ltd. | 103649 | Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized | Rho(D) Immune Globulin Intravenous (Human) | 351(a) | 1500IU | For Injection | Intramuscular | Vial | Disc | Licensed | April 2, 1996 | 0 | Original | 2098 | 003 | CBER | March 24, 2002 | |||||||||
|
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Kamada Ltd. | 103649 | Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized | Rho(D) Immune Globulin Intravenous (Human) | 351(a) | 1500IU | For Injection | Intravenous | Vial | Disc | Licensed | April 2, 1996 | 0 | Original | 2098 | 004 | CBER | March 24, 2002 | |||||||||
|
|
Kamada Ltd. | 103649 | Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized | Rho(D) Immune Globulin Intravenous (Human) | 351(a) | 600IU | For Injection | Intramuscular | Vial | Disc | Licensed | April 2, 1996 | 0 | Original | 2098 | 005 | CBER | March 24, 2002 | |||||||||
|
|
Kamada Ltd. | 103649 | Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized | Rho(D) Immune Globulin Intravenous (Human) | 351(a) | 600IU | For Injection | Intravenous | Vial | Disc | Licensed | April 2, 1996 | 0 | Original | 2098 | 006 | CBER | March 24, 2002 | |||||||||
|
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Kamada Ltd. | 103649 | Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized | Rho(D) Immune Globulin Intravenous (Human) | 351(a) | 15000IU | Injection | Intramuscular | Vial | Disc | Licensed | March 31, 2005 | 5107 | Supplement | 2098 | 007 | CBER | March 24, 2002 | |||||||||
|
|
Kamada Ltd. | 103649 | Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized | Rho(D) Immune Globulin Intravenous (Human) | 351(a) | 15000IU | Injection | Intravenous | Vial | Disc | Licensed | March 31, 2005 | 5107 | Supplement | 2098 | 008 | CBER | March 24, 2002 | |||||||||
|
|
Kamada Ltd. | 103649 | Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized | Rho(D) Immune Globulin Intravenous (Human) | 351(a) | 5000IU | Injection | Intramuscular | Vial | Disc | Licensed | March 31, 2005 | 5107 | Supplement | 2098 | 009 | CBER | March 24, 2002 | |||||||||
|
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Kamada Ltd. | 103649 | Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized | Rho(D) Immune Globulin Intravenous (Human) | 351(a) | 5000IU | Injection | Intravenous | Vial | Disc | Licensed | March 31, 2005 | 5107 | Supplement | 2098 | 010 | CBER | March 24, 2002 | |||||||||
|
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Kamada Ltd. | 103649 | Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized | Rho(D) Immune Globulin Intravenous (Human) | 351(a) | 2500IU | Injection | Intramuscular | Vial | Disc | Licensed | March 31, 2005 | 5107 | Supplement | 2098 | 011 | CBER | March 24, 2002 | |||||||||
|
|
Kamada Ltd. | 103649 | Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized | Rho(D) Immune Globulin Intravenous (Human) | 351(a) | 2500IU | Injection | Intravenous | Vial | Disc | Licensed | March 31, 2005 | 5107 | Supplement | 2098 | 012 | CBER | March 24, 2002 | |||||||||
|
|
Kamada Ltd. | 103649 | Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized | Rho(D) Immune Globulin Intravenous (Human) | 351(a) | 1500IU | Injection | Intramuscular | Vial | Rx | Licensed | March 31, 2005 | 5107 | Supplement | 2098 | 013 | CBER | March 24, 2002 | |||||||||
|
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Kamada Ltd. | 103649 | Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized | Rho(D) Immune Globulin Intravenous (Human) | 351(a) | 1500IU | Injection | Intravenous | Vial | Rx | Licensed | March 31, 2005 | 5107 | Supplement | 2098 | 014 | CBER | March 24, 2002 | |||||||||
|
|
Kamada Ltd. | 103649 | Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized | Rho(D) Immune Globulin Intravenous (Human) | 351(a) | 600IU | Injection | Intramuscular | Vial | Disc | Licensed | March 31, 2005 | 5107 | Supplement | 2098 | 015 | CBER | March 24, 2002 | |||||||||
|
|
Kamada Ltd. | 103649 | Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized | Rho(D) Immune Globulin Intravenous (Human) | 351(a) | 600IU | Injection | Intravenous | Vial | Disc | Licensed | March 31, 2005 | 5107 | Supplement | 2098 | 016 | CBER | March 24, 2002 | |||||||||
|
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Kamada Ltd. | 103649 | Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized | Rho(D) Immune Globulin Intravenous (Human) | 351(a) | 15000IU | Injection | Intravenous | Vial | Disc | Licensed | December 18, 2015 | 5690 | Supplement | 2098 | 017 | CBER | March 24, 2002 | |||||||||
|
|
Kamada Ltd. | 103649 | Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized | Rho(D) Immune Globulin Intravenous (Human) | 351(a) | 15000IU | Injection | Intramuscular | Vial | Disc | Licensed | December 18, 2015 | 5690 | Supplement | 2098 | 018 | CBER | March 24, 2002 | |||||||||
|
|
Sandoz Inc. | 761362 | Wyost | denosumab-bbdz | 351(k) Interchangeable | 120MG/1.7ML (70MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | March 5, 2024 | March 5, 2024 | denosumab | Xgeva | Original | 2003 | 002 | CDER | 45959 | |||||||
|
|
Samsung Bioepis Co., Ltd. | 761392 | Xbryk | denosumab-dssb | 351(k) Interchangeable | 120MG/1.7ML (70MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | February 13, 2025 | October 29, 2025 | denosumab | Xgeva | Original | 2046 | 002 | CDER | ||||||||
|
|
Grifols Therapeutics LLC | 125683 | Xembify | immune globulin subcutaneous, human-klhw | 351(a) | 4GM MG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | July 3, 2019 | 0 | Original | 1871 | 001 | CBER | ||||||||||
|
|
Grifols Therapeutics LLC | 125683 | Xembify | immune globulin subcutaneous, human-klhw | 351(a) | 10GM MG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | July 3, 2019 | 0 | Original | 1871 | 002 | CBER | ||||||||||
|
|
Grifols Therapeutics LLC | 125683 | Xembify | immune globulin subcutaneous, human-klhw | 351(a) | 2GM MG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | July 3, 2019 | 0 | Original | 1871 | 003 | CBER | ||||||||||
|
|
Grifols Therapeutics LLC | 125683 | Xembify | immune globulin subcutaneous, human-klhw | 351(a) | 1GM MG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | July 3, 2019 | 0 | Original | 1871 | 004 | CBER | ||||||||||
|
|
Genzyme Corporation | 761261 | Xenpozyme | olipudase alfa-rpcp | 351(a) | 20MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 31, 2022 | Original | 1596 | 001 | CDER | August 31, 2029 | ||||||||||
|
|
Genzyme Corporation | 761261 | Xenpozyme | olipudase alfa-rpcp | 351(a) | 4MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 31, 2023 | 1 | Supplement | 1596 | 002 | CDER | August 31, 2029 | |||||||||
|
|
Merz Pharmaceuticals GmbH c/o Merz Pharmaceuticals LLC | 125360 | Xeomin | incobotulinumtoxinA | 351(a) | 50UNITS | For Injection | Intramuscular, Intraglandular | Single-Dose Vial | Rx | Licensed | July 30, 2010 | Original | 1830 | 001 | CDER | |||||||||||
|
|
Merz Pharmaceuticals GmbH c/o Merz Pharmaceuticals LLC | 125360 | Xeomin | incobotulinumtoxinA | 351(a) | 100UNITS | For Injection | Intramuscular, Intraglandular | Single-Dose Vial | Rx | Licensed | July 30, 2010 | Original | 1830 | 002 | CDER | |||||||||||
|
|
Merz Pharmaceuticals GmbH c/o Merz Pharmaceuticals LLC | 125360 | Xeomin | incobotulinumtoxinA | 351(a) | 200UNITS | For Injection | Intramuscular, Intraglandular | Single-Dose Vial | Rx | Licensed | November 20, 2015 | 66 | Supplement | 1830 | 003 | CDER | ||||||||||
|
|
Amgen Inc. | 125320 | Xgeva | denosumab | 351(a) | 120MG/1.7ML (70MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | November 18, 2010 | 7 | Supplement | 1080 | 003 | CDER | December 5, 2021 | Yes | ||||||||
|
|
Auxilium Pharmaceuticals, Inc. | 125338 | Xiaflex | collagenase clostridium histolyticum | 351(a) | 0.9MG | For Injection | Intralesional | Single-Dose Vial | Rx | Licensed | February 2, 2010 | Original | 1816 | 001 | CDER | December 6, 2020 | ||||||||||
|
|
Eli Lilly and Company | 125029 | Xigris | drotrecogin alfa | 351(a) | 5MG | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | November 21, 2001 | Original | 1611 | 001 | CDER | |||||||||||
|
|
Eli Lilly and Company | 125029 | Xigris | drotrecogin alfa | 351(a) | 20MG | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | November 21, 2001 | Original | 1611 | 002 | CDER | |||||||||||
|
|
Genentech, Inc. | 103976 | Xolair | omalizumab | 351(a) | 150MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | June 20, 2003 | Original | 1048 | 001 | CDER | Yes | ||||||||||
|
|
Genentech, Inc. | 103976 | Xolair | omalizumab | 351(a) | 75MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | September 28, 2018 | 5231 | Supplement | 1048 | 002 | CDER | Yes | |||||||||
|
|
Genentech, Inc. | 103976 | Xolair | omalizumab | 351(a) | 150MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | September 28, 2018 | 5231 | Supplement | 1048 | 003 | CDER | Yes | |||||||||
|
|
Genentech, Inc. | 103976 | Xolair | omalizumab | 351(a) | 300MG/2ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | August 17, 2023 | 5242 | Supplement | 1048 | 004 | CDER | Yes | |||||||||
|
|
Genentech, Inc. | 103976 | Xolair | omalizumab | 351(a) | 75MG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | August 17, 2023 | 5242 | Supplement | 1048 | 005 | CDER | Yes | |||||||||
|
|
Genentech, Inc. | 103976 | Xolair | omalizumab | 351(a) | 150MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | August 17, 2023 | 5242 | Supplement | 1048 | 006 | CDER | Yes | |||||||||
|
|
Genentech, Inc. | 103976 | Xolair | omalizumab | 351(a) | 300MG/2ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | August 17, 2023 | 5242 | Supplement | 1048 | 007 | CDER | Yes | |||||||||
|
|
Hikma Pharmaceuticals USA Inc. | 761439 | Xtrenbo | denosumab-qbde | 351(k) Interchangeable | 120MG/1.7ML (70MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | September 26, 2025 | October 29, 2025 | denosumab | Xgeva | Original | 2356 | 002 | CDER | ||||||||
|
|
Novo Nordisk Inc. | 208583 | Xultophy 100/3.6 | insulin degludec and liraglutide | 351(a) | 300UNITS/3ML (100UNITS/ML); 10.8MG/3ML (3.6MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | November 21, 2016 | Original | 1261 | 001 | CDER | |||||||||||
|
|
Wyeth Pharmaceuticals LLC | 125264 | Xyntha, Xyntha Solofuse | Antihemophilic Factor (Recombinant), Plasma/Albumin Free | 351(a) | 2000IU | For Injection | Intravenous | Pre-Filled Syringe | Rx | Licensed | February 21, 2008 | 0 | Original | 0003 | 001 | CBER | ||||||||||
|
|
Wyeth Pharmaceuticals LLC | 125264 | Xyntha, Xyntha Solofuse | Antihemophilic Factor (Recombinant), Plasma/Albumin Free | 351(a) | 2000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 21, 2008 | 0 | Original | 0003 | 002 | CBER | ||||||||||
|
|
Wyeth Pharmaceuticals LLC | 125264 | Xyntha, Xyntha Solofuse | Antihemophilic Factor (Recombinant), Plasma/Albumin Free | 351(a) | 1000IU | For Injection | Intravenous | Pre-Filled Syringe | Rx | Licensed | February 21, 2008 | 0 | Original | 0003 | 003 | CBER | ||||||||||
|
|
Wyeth Pharmaceuticals LLC | 125264 | Xyntha, Xyntha Solofuse | Antihemophilic Factor (Recombinant), Plasma/Albumin Free | 351(a) | 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 21, 2008 | 0 | Original | 0003 | 004 | CBER | ||||||||||
|
|
Wyeth Pharmaceuticals LLC | 125264 | Xyntha, Xyntha Solofuse | Antihemophilic Factor (Recombinant), Plasma/Albumin Free | 351(a) | 250IU | For Injection | Intravenous | Pre-Filled Syringe | Rx | Licensed | February 21, 2008 | 0 | Original | 0003 | 005 | CBER | ||||||||||
|
|
Wyeth Pharmaceuticals LLC | 125264 | Xyntha, Xyntha Solofuse | Antihemophilic Factor (Recombinant), Plasma/Albumin Free | 351(a) | 250IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 21, 2008 | 0 | Original | 0003 | 006 | CBER | ||||||||||
|
|
Wyeth Pharmaceuticals LLC | 125264 | Xyntha, Xyntha Solofuse | Antihemophilic Factor (Recombinant), Plasma/Albumin Free | 351(a) | 500IU | For Injection | Intravenous | Pre-Filled Syringe | Rx | Licensed | February 21, 2008 | 0 | Original | 0003 | 007 | CBER | ||||||||||
|
|
Wyeth Pharmaceuticals LLC | 125264 | Xyntha, Xyntha Solofuse | Antihemophilic Factor (Recombinant), Plasma/Albumin Free | 351(a) | 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 21, 2008 | 0 | Original | 0003 | 008 | CBER | ||||||||||
|
|
Wyeth Pharmaceuticals LLC | 125264 | Xyntha, Xyntha Solofuse | Antihemophilic Factor (Recombinant), Plasma/Albumin Free | 351(a) | 3000IU | For Injection | Intravenous | Pre-Filled Syringe | Rx | Licensed | August 6, 2010 | 492 | Supplement | 0003 | 009 | CBER | ||||||||||
|
|
Omeros Corporation | 761152 | Yartemlea | narsoplimab-wuug | 351(a) | 370MG/2ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | December 23, 2025 | Original | 2141 | 001 | CDER | |||||||||||
|
|
Bristol-Myers Squibb Company | 125377 | Yervoy | ipilimumab | 351(a) | 50MG/10ML (5MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 25, 2011 | Original | 1713 | 001 | CDER | October 2, 2027 | ||||||||||
|
|
Bristol-Myers Squibb Company | 125377 | Yervoy | ipilimumab | 351(a) | 200MG/40ML (5MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 25, 2011 | Original | 1713 | 002 | CDER | October 2, 2027 | ||||||||||
|
|
Biocon Biologics Inc. | 761274 | Yesafili | aflibercept-jbvf | 351(k) Interchangeable | 2MG/0.05ML | Injection | Intravitreal | Single-Dose Vial | Rx | Licensed | May 20, 2024 | May 20, 2024 | aflibercept | Eylea | Original | 2324 | 001 | CDER | Date TBD | |||||||
|
|
Biocon Biologics Inc. | 761274 | Yesafili | aflibercept-jbvf | 351(k) Biosimilar | 2MG/0.05ML | Injection | Intravitreal | Pre-Filled Syringe | Rx | Licensed | January 13, 2026 | aflibercept | Eylea | 1 | Supplement | 2324 | 002 | CDER | ||||||||
|
|
Kite Pharma, Inc. | 125643 | Yescarta | axicabtagene ciloleucel | 351(a) | 2 × 10^6 CAR-POSITIVE VIABLE T CELLS PER KG OF BODY WEIGHT | Injection | Intravenous | Bag | Rx | Licensed | October 18, 2017 | 0 | Original | 2064 | 001 | CBER | April 1, 2029 | |||||||||
|
|
Biocon Biologics Inc. | 761406 | Yesintek | ustekinumab-kfce | 351(k) Interchangeable | 90MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | November 29, 2024 | April 30, 2025 | ustekinumab | Stelara | Original | 2324 | 003 | CDER | ||||||||
|
|
Biocon Biologics Inc. | 761406 | Yesintek | ustekinumab-kfce | 351(k) Interchangeable | 45MG/0.5ML | Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | November 29, 2024 | April 30, 2025 | ustekinumab | Stelara | Original | 2324 | 001 | CDER | ||||||||
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Biocon Biologics Inc. | 761406 | Yesintek | ustekinumab-kfce | 351(k) Interchangeable | 45MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | November 29, 2024 | April 30, 2025 | ustekinumab | Stelara | Original | 2324 | 002 | CDER | ||||||||
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Biocon Biologics Inc. | 761406 | Yesintek | ustekinumab-kfce | 351(k) Interchangeable | 130MG/26ML (5MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 29, 2024 | April 30, 2025 | ustekinumab | Stelara | Original | 2324 | 004 | CDER | ||||||||
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Sanofi Pasteur Inc. | 103915 | Yf-Vax | Yellow Fever Vaccine | 351(a) | 23.7PFU/.5ML | For Injection | Subcutaneous | Multi-Dose Vial | Disc | Licensed | December 9, 1999 | 0 | Original | 1725 | 001 | CBER | ||||||||||
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Sanofi Pasteur Inc. | 103915 | Yf-Vax | Yellow Fever Vaccine | 351(a) | 4.74PFU/.5ML | For Injection | Subcutaneous | Single-Dose Vial | Rx | Licensed | December 9, 1999 | 0 | Original | 1725 | 002 | CBER | ||||||||||
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Biotest AG | 125810 | YIMMUGO | immune globulin intravenous, human-dira | 351(a) | 5G/50ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 13, 2024 | 0 | Original | 2332 | 001 | CBER | ||||||||||
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Biotest AG | 125810 | YIMMUGO | immune globulin intravenous, human-dira | 351(a) | 10G/100ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 13, 2024 | 0 | Original | 2332 | 002 | CBER | ||||||||||
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Biotest AG | 125810 | YIMMUGO | immune globulin intravenous, human-dira | 351(a) | 20G/200ML | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 13, 2024 | 0 | Original | 2332 | 003 | CBER | ||||||||||
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CELLTRION, Inc. | 761219 | Yuflyma | adalimumab-aaty | 351(k) Interchangeable | 40MG/0.4ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | May 23, 2023 | May 21, 2025 | adalimumab | Humira | Original | 16 | 1996 | 001 | CDER | |||||||
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CELLTRION, Inc. | 761219 | Yuflyma | adalimumab-aaty | 351(k) Interchangeable | 40MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | May 23, 2023 | May 20, 2025 | adalimumab | Humira | Original | 9 | 1996 | 002 | CDER | |||||||
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CELLTRION, Inc. | 761219 | Yuflyma | adalimumab-aaty | 351(k) Interchangeable | 80MG/0.8ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | September 29, 2023 | May 21, 2025 | adalimumab | Humira | 1 | Supplement | 16 | 1996 | 003 | CDER | ||||||
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CELLTRION, Inc. | 761219 | Yuflyma | adalimumab-aaty | 351(k) Interchangeable | 80MG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | September 29, 2023 | April 7, 2025 | adalimumab | Humira | 1 | Supplement | 17 | 1996 | 004 | CDER | ||||||
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CELLTRION, Inc. | 761219 | Yuflyma | adalimumab-aaty | 351(k) Interchangeable | 20MG/0.2ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | September 29, 2023 | April 7, 2025 | adalimumab | Humira | 1 | Supplement | 17 | 1996 | 005 | CDER | ||||||
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Hong Kong King-Friend Industrial Company Limited | 761216 | Yusimry | adalimumab-aqvh | 351(k) Biosimilar | 40MG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | December 17, 2021 | adalimumab | Humira | Original | 2375 | 001 | CDER | |||||||||
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Hong Kong King-Friend Industrial Company Limited | 761216 | Yusimry | adalimumab-aqvh | 351(k) Biosimilar | 40MG/0.8ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | February 27, 2023 | adalimumab | Humira | 1 | Supplement | 2375 | 002 | CDER | ||||||||
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Sanofi-Aventis U.S. LLC | 125418 | Zaltrap | Ziv-Aflibercept | 351(a) | 100MG/4ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 3, 2012 | Original | 1752 | 001 | CDER | |||||||||||
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Sanofi-Aventis U.S. LLC | 125418 | Zaltrap | Ziv-Aflibercept | 351(a) | 200MG/8ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | August 3, 2012 | Original | 1752 | 002 | CDER | |||||||||||
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Sandoz Inc. | 125553 | Zarxio | filgrastim-sndz | 351(k) Biosimilar | 300MCG/0.5ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | March 6, 2015 | filgrastim | Neupogen | Original | 2003 | 001 | CDER | |||||||||
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Sandoz Inc. | 125553 | Zarxio | filgrastim-sndz | 351(k) Biosimilar | 480MCG/0.8ML | Injection | Intravenous, Subcutaneous | Pre-Filled Syringe | Rx | Licensed | March 6, 2015 | filgrastim | Neupogen | Original | 2003 | 002 | CDER | |||||||||
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Sandoz Inc. | 125553 | Zarxio | filgrastim-sndz | 351(k) Biosimilar | 300MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | August 9, 2024 | filgrastim | Neupogen | 32 | Supplement | 2003 | 003 | CDER | ||||||||
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Sandoz Inc. | 125553 | Zarxio | filgrastim-sndz | 351(k) Biosimilar | 480MCG/1.6ML (300MCG/ML) | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Disc | Licensed | August 9, 2024 | filgrastim | Neupogen | 32 | Supplement | 2003 | 004 | CDER | ||||||||
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CSL Behring LLC | 125078 | Zemaira | Alpha-1-Proteinase Inhibitor (Human) | 351(a) | 1000MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | July 8, 2003 | 0 | Original | 1767 | 001 | CBER | ||||||||||
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CSL Behring LLC | 125078 | Zemaira | Alpha-1-Proteinase Inhibitor (Human) | 351(a) | 4000MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 16, 2019 | 818 | Supplement | 1767 | 002 | CBER | ||||||||||
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CSL Behring LLC | 125078 | Zemaira | Alpha-1-Proteinase Inhibitor (Human) | 351(a) | 5000MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 16, 2019 | 818 | Supplement | 1767 | 003 | CBER | ||||||||||
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Hoffmann-La Roche Inc. | 103749 | Zenapax | daclizumab | 351(a) | 25MG/5ML | Injection | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | December 10, 1997 | 0136 | 001 | CDER | ||||||||||||
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Zenpep, LLC | 022210 | Zenpep | pancrelipase | 351(a) | 5,000USP UNITS; 17,000USP UNITS; 24,000USP UNITS | Capsule, Delayed Release | Oral | Rx | Licensed | August 27, 2009 | Original | 2198 | 001 | CDER | ||||||||||||
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Zenpep, LLC | 022210 | Zenpep | pancrelipase | 351(a) | 10,000USP UNITS; 32,000USP UNITS; 42,000USP UNITS | Capsule, Delayed Release | Oral | Rx | Licensed | August 27, 2009 | Original | 2198 | 002 | CDER | ||||||||||||
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Zenpep, LLC | 022210 | Zenpep | pancrelipase | 351(a) | 15,000USP UNITS; 47,000USP UNITS; 63,000USP UNITS | Capsule, Delayed Release | Oral | Rx | Licensed | August 27, 2009 | Original | 2198 | 003 | CDER | ||||||||||||
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Zenpep, LLC | 022210 | Zenpep | pancrelipase | 351(a) | 20,000USP UNITS; 63,000USP UNITS; 84,000USP UNITS | Capsule, Delayed Release | Oral | Rx | Licensed | August 27, 2009 | Original | 2198 | 004 | CDER | ||||||||||||
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Zenpep, LLC | 022210 | Zenpep | pancrelipase | 351(a) | 3,000USP UNITS; 10,000USP UNITS; 14,000USP UNITS | Capsule, Delayed Release | Oral | Rx | Licensed | June 15, 2011 | 6 | Supplement | 2198 | 005 | CDER | |||||||||||
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Zenpep, LLC | 022210 | Zenpep | pancrelipase | 351(a) | 25,000USP UNITS; 79,000USP UNITS; 105,000USP UNITS | Capsule, Delayed Release | Oral | Rx | Licensed | July 13, 2011 | 5 | Supplement | 2198 | 006 | CDER | |||||||||||
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Zenpep, LLC | 022210 | Zenpep | pancrelipase | 351(a) | 40,000USP UNITS; 126,000USP UNITS; 168,000USP UNITS | Capsule, Delayed Release | Oral | Rx | Licensed | March 25, 2014 | 16 | Supplement | 2198 | 007 | CDER | |||||||||||
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Zenpep, LLC | 022210 | Zenpep | pancrelipase | 351(a) | 60,000USP UNITS; 189,600USP UNITS; 252,600USP UNITS | Capsule, Delayed Release | Oral | Rx | Licensed | October 27, 2023 | 27 | Supplement | 2198 | 008 | CDER | |||||||||||
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Acrotech Biopharma Inc. | 125019 | Zevalin | ibritumomab tiuxetan | 351(a) | 3.2MG/2ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | February 19, 2002 | Original | 2159 | 001 | CDER | February 19, 2009 | ||||||||||
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Abeona Therapeutics Inc. | 125807 | zevaskyn | Prademagene zamikeracel | 351(a) | 41.25CM^2 | Cellular Sheet | Topical | Tray & Lid | Rx | Licensed | April 28, 2025 | 0 | Original | 2329 | 001 | CBER | ||||||||||
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Sandoz Inc. | 761045 | Ziextenzo | pegfilgrastim-bmez | 351(k) Biosimilar | 6MG/0.6ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | November 4, 2019 | pegfilgrastim | Neulasta | Original | 2003 | 001 | CDER | |||||||||
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Jazz Pharmaceuticals Ireland Limited | 761416 | Ziihera | zanidatamab-hrii | 351(a) | 300MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | November 20, 2024 | Original | 2167 | 001 | CDER | November 20, 2031 | ||||||||||
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Biogen Inc. | 761029 | Zinbryta | daclizumab | 351(a) | 150MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | Voluntarily Revoked | May 27, 2016 | Original | 1697 | 001 | CDER | |||||||||||
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Biogen Inc. | 761029 | Zinbryta | daclizumab | 351(a) | 150MG/ML | Injection | Subcutaneous | Autoinjector | Disc | Voluntarily Revoked | May 26, 2017 | 1 | Supplement | 1697 | 002 | CDER | ||||||||||
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Merck Sharp & Dohme LLC | 761046 | Zinplava | bezlotoxumab | 351(a) | 1,000MG/40ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | October 21, 2016 | Original | 0002 | 001 | CDER | |||||||||||
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Pfizer Inc. | 761099 | Zirabev | bevacizumab-bvzr | 351(k) Biosimilar | 100MG/4ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 27, 2019 | bevacizumab | Avastin | Original | 2001 | 001 | CDER | |||||||||
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Pfizer Inc. | 761099 | Zirabev | bevacizumab-bvzr | 351(k) Biosimilar | 400MG/16ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | June 27, 2019 | bevacizumab | Avastin | Original | 2001 | 002 | CDER | |||||||||
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Novartis Gene Therapies, Inc. | 125694 | Zolgensma | onasemnogene abeparvovec-xioi | 351(a) | 2x10^13VG/ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | May 24, 2019 | 0 | Original | 2250 | 001 | CBER | May 24, 2019 | November 24, 2031 | November 24, 2026 | |||||||
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Ferring Pharmaceuticals Inc. | 019774 | Zomacton | somatropin | 351(a) | 4.8MG | For Injection | Subcutaneous | Multi-Dose Vial | Disc | Licensed | May 25, 1995 | Original | 2112 | 001 | CDER | |||||||||||
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Ferring Pharmaceuticals Inc. | 019774 | Zomacton | somatropin | 351(a) | 5MG | For Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | January 4, 2002 | 8 | Supplement | 2112 | 002 | CDER | ||||||||||
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Ferring Pharmaceuticals Inc. | 019774 | Zomacton | somatropin | 351(a) | 10MG | For Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | March 7, 2012 | 25 | Supplement | 2112 | 003 | CDER | ||||||||||
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EMD Serono, Inc. | 020604 | Zorbtive/Serostim | somatropin | 351(a) | 8.8MG | For Injection | Subcutaneous | Multi-Dose Vial | Disc | Licensed | November 19, 2001 | 19 | Supplement | 1773 | 004 | CDER | ||||||||||
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|
Merck Sharp & Dohme LLC | 125123 | Zostavax | Zoster Vaccine Live | 351(a) | 0.65ML | For Injection | Subcutaneous | Single-Dose Vial | Disc | Licensed | May 25, 2006 | 0 | Original | 0002 | 001 | CBER | ||||||||||
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CELLTRION, Inc. | 761358 | Zymfentra | infliximab-dyyb | 351(a) | 120MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | October 20, 2023 | Original | 1996 | 001 | CDER | |||||||||||
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CELLTRION, Inc. | 761358 | Zymfentra | infliximab-dyyb | 351(a) | 120MG/ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | October 20, 2023 | Original | 1996 | 002 | CDER | |||||||||||
|
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ADC Therapeutics SA | 761196 | Zynlonta | loncastuximab tesirine-lpyl | 351(a) | 10MG | For Injection | Intravenous | Single-Dose Vial | Rx | Licensed | April 23, 2021 | Original | 2166 | 001 | CDER | April 23, 2028 | ||||||||||
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Genetix Biotherapeutics Inc. | 125717 | Zynteglo | betibeglogene autotemcel | 351(a) | 1.7-20 X 10^6CELL/ML | For Injection | Intravenous | Bag | Rx | Licensed | August 17, 2022 | 0 | Original | 2425 | 001 | CBER | August 17, 2022 | August 17, 2034 | August 17, 2029 | |||||||
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Incyte Corporation | 761334 | Zynyz | retifanlimab-dlwr | 351(a) | 500MG/20ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | March 22, 2023 | Original | 2228 | 001 | CDER | March 22, 2030 |
Database last updated: March 24, 2026