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Rebif
interferon beta-1a
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Rebif
Proper name
interferon beta-1a
Licence type
351(a)
BLA number
103780
Applicant
EMD Serono, Inc.
Center
CDER
Presentations
6
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 22MCG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | March 7, 2002 |
| 22MCG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | December 21, 2012 |
| 44MCG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | March 7, 2002 |
| 44MCG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | December 21, 2012 |
| 8.8MCG/0.2ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | December 17, 2004 |
| 8.8MCG/0.2ML | Injection | Subcutaneous | Autoinjector | Rx | December 21, 2012 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |