Product Details for: Retacrit Product Label Grayed out Product Label links indicate that there is no product label available for the product.
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Product Number | Dosage Form | Route of Administration | Strength | Product Presentation | License Type | Proprietary Name | Marketing Status |
---|---|---|---|---|---|---|---|
001 | Injection | Intravenous, Subcutaneous | 2,000UNITS/ML | Single-Dose Vial | 351(k) Biosimilar | Retacrit | Rx |
002 | Injection | Intravenous, Subcutaneous | 3,000UNITS/ML | Single-Dose Vial | 351(k) Biosimilar | Retacrit | Rx |
003 | Injection | Intravenous, Subcutaneous | 4,000UNITS/ML | Single-Dose Vial | 351(k) Biosimilar | Retacrit | Rx |
004 | Injection | Intravenous, Subcutaneous | 10,000UNITS/ML | Single-Dose Vial | 351(k) Biosimilar | Retacrit | Rx |
005 | Injection | Intravenous, Subcutaneous | 40,000UNITS/ML | Single-Dose Vial | 351(k) Biosimilar | Retacrit | Rx |
006 | Injection | Intravenous, Subcutaneous | 20,000UNITS/2ML (10,000UNITS/ML) | Multi-Dose Vial | 351(k) Biosimilar | Retacrit | Rx |
007 | Injection | Intravenous, Subcutaneous | 20,000UNITS/ML | Multi-Dose Vial | 351(k) Biosimilar | Retacrit | Rx |
Proper Name
epoetin alfa-epbx
Reference Product Proper Name
epoetin alfa
Reference Product Proprietary Name
Procrit
BLA Number
125545
Applicant
Hospira Inc., a Pfizer Company
Original Approval Date
May 15, 2018
Date of First Licensure