Home Applications 103836 Application 103836
Type BLA
Sponsor VIDARA THERAPEUTICS RESEARCH LTD Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103836 Actimmune interferon gamma-1b 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ACTIMMUNE INTERFERON GAMMA-1B VIAL; SINGLE-USE 100UG/0.5ML 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 75987-111 ACTIMMUNE Interferon gamma-1b Horizon Therapeutics USA, Inc. BLA Current 75987-111 ACTIMMUNE Interferon gamma-1b Horizon Therapeutics USA, Inc. BLA Current 75987-111 ACTIMMUNE Interferon gamma-1b Horizon Therapeutics USA, Inc. BLA Current 75987-111 ACTIMMUNE Interferon gamma-1b Horizon Therapeutics USA, Inc. BLA Current 75987-111 ACTIMMUNE Interferon gamma-1b Horizon Pharma Inc. BLA Current 75987-111 ACTIMMUNE Interferon gamma-1b Horizon Therapeutics USA, Inc. BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 31692 SUPPL 2015-09-01 18670 SUPPL 2015-08-28 23944 ORIG 2007-03-09 39728 SUPPL 2007-02-23 31691 SUPPL 2007-02-12 39727 SUPPL 2004-12-06 31690 SUPPL 2004-12-06 31689 SUPPL 2004-03-10