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Pegasys
peginterferon alfa-2a
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Pegasys
Proper name
peginterferon alfa-2a
Licence type
351(a)
BLA number
103964
Applicant
pharmaand GmbH
Center
CDER
Presentations
4
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 135MCG/0.5ML | Injection | Subcutaneous | Autoinjector | Disc | September 29, 2011 |
| 180MCG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | January 7, 2004 |
| 180MCG/0.5ML | Injection | Subcutaneous | Autoinjector | Disc | September 29, 2011 |
| 180MCG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | October 16, 2002 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |