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Betaseron

interferon beta-1b

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Betaseron
Proper name
interferon beta-1b
Licence type
351(a)
BLA number
103471
Applicant
Bayer HealthCare Pharmaceuticals Inc.
Center
CDER
Presentations
1
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
0.3MG For Injection Subcutaneous Single-Dose Vial Rx July 23, 1993

Sources for this page

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