Home Applications 125504 Application 125504
Type BLA
Sponsor NOVARTIS PHARMS CORP Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125504 Cosentyx secukinumab 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 COSENTYX SECUKINUMAB INJECTABLE;INJECTION 150MG/ML 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 · 13 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0078-0639 COSENTYX secukinumab Novartis Pharmaceuticals Corporation BLA Current 0078-0639 COSENTYX secukinumab Novartis Pharmaceuticals Corporation BLA Current 0078-0639 COSENTYX secukinumab Novartis Pharmaceuticals Corporation BLA Current 0078-0639 COSENTYX secukinumab Novartis Pharmaceuticals Corporation BLA Current 0078-0639 COSENTYX secukinumab Novartis Pharmaceuticals Corporation BLA Current 0078-0639 COSENTYX secukinumab Novartis Pharmaceuticals Corporation BLA Current 0078-0639 COSENTYX secukinumab Novartis Pharmaceuticals Corporation BLA Current 0078-0639 COSENTYX secukinumab Novartis Pharmaceuticals Corporation BLA Current 0078-0639 COSENTYX secukinumab Novartis Pharmaceuticals Corporation BLA Current 0078-1056 COSENTYX secukinumab Novartis Pharmaceuticals Corporation BLA Current 0078-1056 COSENTYX secukinumab Novartis Pharmaceuticals Corporation BLA Current 0078-1056 COSENTYX secukinumab Novartis Pharmaceuticals Corporation BLA Current 0078-1056 COSENTYX secukinumab Novartis Pharmaceuticals Corporation BLA Current