Home Applications 761468 Application 761468
Type BLA
Sponsor GILEAD SCIENCES INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761468 Hepcludex bulevirtide-gmod 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HEPCLUDEX BULEVIRTIDE-GMOD INJECTION;POWDER,FOR SOLUTION 8.5MG 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 HEPCLUDEX BULEVIRTIDE Gilead Sciences, Inc. 12391cc2-38c2-4cf5-86d3-2be9370127fc 2026-05-22 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761468
Documents# Document, Submission type, Date table Document Submission type Date 86018 ORIG 2026-05-26 86017 ORIG 2026-05-26