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Neupogen
filgrastim
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Neupogen
Proper name
filgrastim
Licence type
351(a)
BLA number
103353
Applicant
Amgen Inc.
Center
CDER
Presentations
4
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 300MCG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | June 28, 2000 |
| 300MCG/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | February 20, 1991 |
| 480MCG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | June 28, 2000 |
| 480MCG/1.6ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | February 20, 1991 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | March 30, 2022 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |