On this page
Procrit
epoetin alfa
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Procrit
Proper name
epoetin alfa
Licence type
351(a)
BLA number
103234
Applicant
Amgen Inc.
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 40,000UNITS/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | — |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | December 31, 1997 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |