Home Applications 125290 Application 125290
Type BLA
Sponsor NOVARTIS PHARMS Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125290 Extavia interferon beta-1b 351(a) Disc 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EXTAVIA INTERFERON BETA-1B INJECTABLE; SUBCUTANEOUS 0.0625MG Yes 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.
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 0078-0569 EXTAVIA Interferon beta-1b Novartis Pharmaceuticals Corporation BLA Current 0078-0569 EXTAVIA Interferon beta-1b Novartis Pharmaceuticals Corporation BLA Current 0078-0569 EXTAVIA Interferon beta-1b Novartis Pharmaceuticals Corporation BLA Current 0078-0569 EXTAVIA Interferon beta-1b Novartis Pharmaceuticals Corporation BLA Current 0078-0569 EXTAVIA Interferon beta-1b Novartis Pharmaceuticals Corporation BLA Current 0078-0569 EXTAVIA Interferon beta-1b Novartis Pharmaceuticals Corporation BLA Current 0078-0569 EXTAVIA Interferon beta-1b Novartis Pharmaceuticals Corporation BLA Current 0078-0569 EXTAVIA Interferon beta-1b Novartis Pharmaceuticals Corporation BLA Current