Home Applications 761158 Application 761158
Type BLA
Sponsor GLAXOSMITHKLINE Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761158 Blenrep belantamab mafodotin-blmf 351(a) Disc 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BLENREP BELANTAMAB MAFODOTIN-BLMF INJECTABLE;INTRAVENOUS 2.5MG/KG 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 Blenrep BELANTAMAB MAFODOTIN GlaxoSmithKline LLC aef7c34c-fef8-407c-99c0-a68aded53c60 2025-10-23 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Blenrep
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0173-0896 Blenrep Belantamab GlaxoSmithKline LLC BLA Current 0173-0896 Blenrep Belantamab GlaxoSmithKline LLC BLA Current 0173-0896 Blenrep Belantamab GlaxoSmithKline LLC BLA Current 0173-0896 Blenrep Belantamab GlaxoSmithKline LLC BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 70339 SUPPL 2022-03-01 70338 SUPPL 2022-03-01 70314 SUPPL 2022-03-01 69513 SUPPL 2021-12-08 65310 SUPPL 2020-11-25 64469 ORIG 2020-09-01 64241 ORIG 2020-08-10 64208 ORIG 2020-08-06 64207 ORIG 2020-08-06