Home Applications 103471 Application 103471
Type BLA
Sponsor BAYER HEALTHCARE PHARMS Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103471 Betaseron interferon beta-1b 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BETASERON INTERFERON BETA-1B VIAL; SUBCUTANEOUS 0.3 MG No No
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Betaseron INTERFERON BETA-1B Bayer HealthCare Pharmaceuticals Inc. 66311f74-0472-4fa3-848a-06002ca0def5 2026-03-03 Warnings, Adverse reactions Exact identifier application number: BLA103471 ndc (product): 50419-524
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50419-524 Betaseron interferon beta-1b Bayer HealthCare Pharmaceuticals Inc. BLA Current 50419-524 Betaseron interferon beta-1b Bayer HealthCare Pharmaceuticals Inc. BLA Current 50419-524 Betaseron interferon beta-1b Bayer HealthCare Pharmaceuticals Inc. BLA Current 50419-524 Betaseron interferon beta-1b Bayer HealthCare Pharmaceuticals Inc. BLA Current 50419-524 Betaseron interferon beta-1b Bayer HealthCare Pharmaceuticals Inc. BLA Current 50419-524 Betaseron interferon beta-1b Bayer HealthCare Pharmaceuticals Inc. BLA Current 50419-524 Betaseron interferon beta-1b Bayer HealthCare Pharmaceuticals Inc. BLA Current 50419-524 Betaseron interferon beta-1b Bayer HealthCare Pharmaceuticals Inc. BLA Current