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Pegasys Copegus Combination Pack
peginterferon alfa-2a and ribavirin
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Pegasys Copegus Combination Pack
Proper name
peginterferon alfa-2a and ribavirin
Licence type
351(a)
BLA number
125083
Applicant
Hoffmann-La Roche Inc.
Center
CDER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 180MCG/0.5ML & 1200MG | — | — | — | Disc | June 4, 2004 |
| 180MCG/0.5ML & 800MG | — | — | — | Disc | June 4, 2004 |
| 180MCG/0.5ML &1000MG | — | — | — | Disc | June 4, 2004 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |