Home Applications 761485 Application 761485
Type BLA
Sponsor DENALI THERAPEUTICS INC. Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761485 Avlayah tividenofusp alfa-eknm 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AVLAYAH TIVIDENOFUSP ALFA-EKNM INJECTION;POWDER,FOR SOLUTION 150MG/VIAL 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 AVLAYAH TIVIDENOFUSP ALFA-EKNM Denali Therapeutics Inc. 014d92c1-b643-4680-8ca6-f0b3307da915 2026-03-20 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761485
Documents# Document, Submission type, Date table Document Submission type Date 85752 ORIG 2026-04-24 85685 ORIG 2026-04-15 85527 ORIG 2026-03-25