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Neulasta
pegfilgrastim
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Neulasta
Proper name
pegfilgrastim
Licence type
351(a)
BLA number
125031
Applicant
Amgen Inc.
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 6MG/0.6ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | January 31, 2002 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | November 13, 2022 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |