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Plegridy
peginterferon beta-1a
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Plegridy
Proper name
peginterferon beta-1a
Licence type
351(a)
BLA number
125499
Applicant
Biogen Inc.
Center
CDER
Presentations
6
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 125MCG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | August 15, 2014 |
| 125MCG/0.5ML | Injection | Subcutaneous, Intramuscular | Pre-Filled Syringe | Rx | August 15, 2014 |
| 63MCG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | August 15, 2014 |
| 63MCG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | August 15, 2014 |
| 94MCG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | August 15, 2014 |
| 94MCG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | August 15, 2014 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |