Product Details for: Retacrit

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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 Properietary Name
Procrit
BLA Number
125545
Applicant
Hospira Inc., a Pfizer Company
Original Approval Date
May 15, 2018
Date of First Licensure
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