Product Details for: Eloctate Product Label Grayed out Product Label links indicate that there is no product label available for the product.
Product Label Grayed out Product Label links indicate that there is no product label available for the product.
Product Number | Dosage Form | Route of Administration | Strength | Product Presentation | License Type | Proprietary Name | Marketing Status |
---|---|---|---|---|---|---|---|
001 | For Injection | Intravenous | 1500IU | Single-Dose Vial | 351(a) | Eloctate | Rx |
002 | For Injection | Intravenous | 1000IU | Single-Dose Vial | 351(a) | Eloctate | Rx |
003 | For Injection | Intravenous | 2000IU | Single-Dose Vial | 351(a) | Eloctate | Rx |
004 | For Injection | Intravenous | 3000IU | Single-Dose Vial | 351(a) | Eloctate | Rx |
005 | For Injection | Intravenous | 750IU | Single-Dose Vial | 351(a) | Eloctate | Rx |
006 | For Injection | Intravenous | 500IU | Single-Dose Vial | 351(a) | Eloctate | Rx |
007 | For Injection | Intravenous | 250IU | Single-Dose Vial | 351(a) | Eloctate | Rx |
008 | For Injection | Intravenous | 5000IU | Single-Dose Vial | 351(a) | Eloctate | Rx |
009 | For Injection | Intravenous | 6000IU | Single-Dose Vial | 351(a) | Eloctate | Rx |
010 | For Injection | Intravenous | 4000IU | Single-Dose Vial | 351(a) | Eloctate | Rx |
Proper Name
Antihemophilic Factor (Recombinant), Fc Fusion protein
BLA Number
125487
Applicant
Bioverativ Therapeutics, Inc.
Original Approval Date
June 6, 2014
Date of First Licensure