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Pegintron

peginterferon alfa-2b

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Pegintron
Proper name
peginterferon alfa-2b
Licence type
351(a)
BLA number
103949
Applicant
Merck Sharp & Dohme LLC
Center
CDER
Presentations
8
First licensure
—

Presentations

Source: Purple Book
Every strength and presentation recorded in the Purple Book for this product.
Strength Dosage form Route Presentation Status Licensed
120MCG/0.5ML Injection Subcutaneous Autoinjector Disc January 19, 2001
120MCG/0.5ML Injection Subcutaneous Single-Dose Vial Disc January 19, 2001
150MCG/0.5ML Injection Subcutaneous Autoinjector Disc January 19, 2001
150MCG/0.5ML Injection Subcutaneous Single-Dose Vial Disc January 19, 2001
50MCG/0.5ML Injection Subcutaneous Single-Dose Vial Disc January 19, 2001
50MCG/0.5ML Injection Subcutaneous Autoinjector Disc January 19, 2001
80MCG/0.5ML Injection Subcutaneous Autoinjector Disc January 19, 2001
80MCG/0.5ML Injection Subcutaneous Single-Dose Vial Disc January 19, 2001

Sources for this page

Purple Book FDA Licence type, presentations, reference product, exclusivity