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 2026-08-01
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# 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 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