Home Applications 761032 Application 761032
Type BLA
Sponsor VALEANT LUXEMBOURG Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761032 Siliq brodalumab 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SILIQ BRODALUMAB INJECTABLE;INJECTION 210MG/1.5ML 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Siliq BRODALUMAB Bausch Health US LLC 1a550c33-456a-4833-814e-8591aea7c688 2026-05-28 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761032 ndc (product): 0187-0004
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 0187-0004 Siliq Brodalumab Bausch Health US LLC BLA Current 0187-0004 Siliq Brodalumab Bausch Health Americas Inc. BLA Current 0187-0004 Siliq Brodalumab Bausch Health US LLC BLA Current 0187-0004 Siliq Brodalumab Bausch Health US LLC BLA Current 0187-0004 Siliq Brodalumab Bausch Health US LLC BLA Current 0187-0004 Siliq Brodalumab Valeant Pharmaceuticals North America LLC BLA Current 0187-0004 Siliq Brodalumab Bausch Health US LLC BLA Current 0187-0004 Siliq Brodalumab Bausch Health US LLC BLA Current