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Sylatron
peginterferon alfa-2b
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Sylatron
Proper name
peginterferon alfa-2b
Licence type
351(a)
BLA number
103949
Applicant
Merck Sharp & Dohme LLC
Center
CDER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 200MCG | For Injection | Subcutaneous | Single-Dose Vial | Disc | March 29, 2011 |
| 300MCG | For Injection | Subcutaneous | Single-Dose Vial | Disc | March 29, 2011 |
| 600MCG | For Injection | Subcutaneous | Single-Dose Vial | Disc | March 29, 2011 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |