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Purple Book
Database of Licensed Biological Products

Product Details for: Retacrit
Product Label Grayed out Product Label links indicate that there is no product label available for the product.

Product NumberDosage FormRoute of AdministrationStrengthProduct PresentationLicense TypeProprietary NameMarketing Status
001Injection Intravenous, Subcutaneous 2,000UNITS/MLSingle-Dose Vial351(k) BiosimilarRetacritRx
002Injection Intravenous, Subcutaneous 3,000UNITS/MLSingle-Dose Vial351(k) BiosimilarRetacritRx
003Injection Intravenous, Subcutaneous 4,000UNITS/MLSingle-Dose Vial351(k) BiosimilarRetacritRx
004Injection Intravenous, Subcutaneous 10,000UNITS/MLSingle-Dose Vial351(k) BiosimilarRetacritRx
005Injection Intravenous, Subcutaneous 40,000UNITS/MLSingle-Dose Vial351(k) BiosimilarRetacritRx
006Injection Intravenous, Subcutaneous 20,000UNITS/2ML (10,000UNITS/ML)Multi-Dose Vial351(k) BiosimilarRetacritRx
007Injection Intravenous, Subcutaneous 20,000UNITS/MLMulti-Dose Vial351(k) BiosimilarRetacritRx

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