Home Applications 761458 Application 761458
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 761458 Exdensur depemokimab-ulaa 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EXDENSUR DEPEMOKIMAB-ULAA INJECTION 100MG 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 Exdensur DEPEMOKIMAB GlaxoSmithKline LLC 30332b20-2ac0-42ad-a775-d3ca7f5fe29f 2026-06-10 Warnings, Adverse reactions Exact identifier application number: BLA761458
Documents# Document, Submission type, Date table Document Submission type Date 84838 ORIG 2026-01-26 84768 ORIG 2026-01-15 84461 ORIG 2025-12-19