Home Applications 103950 Application 103950
Type BLA
Sponsor BIOVITRUM AB Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103950 Kineret anakinra 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KINERET ANAKINRA VIAL; SUBCUTANEOUS 10MIU/VIAL No No 002 KINERET ANAKINRA VIAL; SUBCUTANEOUS 18MIU/VIAL No No 003 KINERET ANAKINRA VIAL; SUBCUTANEOUS 25MIU/VIAL 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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 66658-234 Kineret anakinra Swedish Orphan Biovitrum AB (publ) BLA Current 66658-234 Kineret anakinra Swedish Orphan Biovitrum AB (publ) BLA Current