Application 761349

Type
BLA
Sponsor
NOVARTIS PHARMS CORP

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761349Cosentyxsecukinumab351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COSENTYXSECUKINUMABINJECTABLE;INJECTION150MGNoNo

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 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COSENTYXSECUKINUMABNovartis Pharmaceuticals Corporation77c4b13e-7df3-42d4-81db-3d0cddb7f67a2026-04-17Warnings, Adverse reactionsExact identifier
application number: BLA761349

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85727SUPPL 2026-04-21
85726SUPPL 2026-04-21
85719SUPPL 2026-04-20
85718SUPPL 2026-04-20
85377SUPPL 2026-03-16
83066SUPPL 2025-08-21
83067SUPPL 2025-08-08
81609SUPPL 2025-03-17
81602SUPPL 2025-03-17
79847SUPPL 2024-10-09
79552ORIG 2024-09-06
79446SUPPL 2024-08-20
79436SUPPL 2024-08-19
76661SUPPL 2023-11-24
76668SUPPL 2023-11-22
75691ORIG 2023-10-10
75683ORIG 2023-10-10