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PegIntron/ Rebetol Combo Pack
peginterferon alfa-2b and ribavirin
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
PegIntron/ Rebetol Combo Pack
Proper name
peginterferon alfa-2b and ribavirin
Licence type
351(a)
BLA number
125196
Applicant
Schering Corporation a subsidiary of Merck & Co., Inc.
Center
CDER
Presentations
4
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 120MCG/0.5ML & 200MG | — | — | — | Disc | June 13, 2008 |
| 150MCG/0.5ML & 200MG | — | — | — | Disc | June 13, 2008 |
| 50MCG/0.5ML & 200MG | — | — | — | Disc | June 13, 2008 |
| 80MCG/0.5ML & 200MG | — | — | — | Disc | June 13, 2008 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |