On this page
Epogen/Procrit
epoetin alfa
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Epogen/Procrit
Proper name
epoetin alfa
Licence type
351(a)
BLA number
103234
Applicant
Amgen Inc.
Center
CDER
Presentations
6
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10,000UNITS/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | June 1, 1989 |
| 2,000UNITS/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | June 1, 1989 |
| 20,000UNITS/2ML (10,000UNITS/ML) | Injection | Intravenous, Subcutaneous | Multi-Dose Vial | Rx | — |
| 20,000UNITS/ML | Injection | Intravenous, Subcutaneous | Multi-Dose Vial | Rx | — |
| 3,000UNITS/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | June 1, 1989 |
| 4,000UNITS/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | June 1, 1989 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | December 31, 1997 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |