Home Applications 125319 Application 125319
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 125319 Ilaris canakinumab 351(a) Disc 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ILARIS CANAKINUMAB INJECTABLE; SUBCUTANEOUS 180MG 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 Ilaris CANAKINUMAB Novartis Pharmaceuticals Corporation 7d271f3b-e4f9-4d80-8dcf-28d49123f80e 2026-06-08 Warnings, Adverse reactions Exact identifier application number: BLA125319 ndc (product): 0078-0734
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 0078-0582 Ilaris canakinumab Novartis Pharmaceuticals Corporation BLA Current 0078-0582 Ilaris canakinumab Novartis Pharmaceuticals Corporation BLA Current 0078-0734 Ilaris canakinumab Novartis Pharmaceuticals Corporation BLA Current 0078-0734 Ilaris canakinumab Novartis Pharmaceuticals Corporation BLA Current 0078-0734 Ilaris canakinumab Novartis Pharmaceuticals Corporation BLA Current 0078-0734 Ilaris canakinumab Novartis Pharmaceuticals Corporation BLA Current 0078-0734 Ilaris canakinumab Novartis Pharmaceuticals Corporation BLA Current 0078-0734 Ilaris canakinumab Novartis Pharmaceuticals Corporation BLA Current