Home Applications 761248 Application 761248
Type BLA
Sponsor ELI LILLY CO Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761248 Kisunla donanemab-azbt 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KISUNLA DONANEMAB-AZBT INJECTABLE;INJECTION 350MG/20ML(17.5MG/ML) No No
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 Kisunla DONANEMAB-AZBT Eli Lilly and Company 190352d4-ef62-4679-b4fa-e846e2766afa 2025-12-30 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761248
Documents# Document, Submission type, Date table Document Submission type Date 82766 SUPPL 2025-07-09 82727 SUPPL 2025-07-02 82722 SUPPL 2025-07-02 79247 ORIG 2024-07-29 78980 ORIG 2024-07-05 78974 ORIG 2024-07-03