Home Applications 761440 Application 761440
Type BLA
Sponsor GLAXOSMITHKLINE LLC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761440 Blenrep belantamab mafodotin-blmf 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BLENREP BELANTAMAB MAFODOTIN-BLMF INJECTABLE;INJECTION 70MG 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 ยท 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Blenrep BELANTAMAB MAFODOTIN GlaxoSmithKline LLC aef7c34c-fef8-407c-99c0-a68aded53c60 2025-10-23 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761440
Documents# Document, Submission type, Date table Document Submission type Date 83926 ORIG 2025-10-27 83912 ORIG 2025-10-24