Home Applications 761127 Application 761127
Type BLA
Sponsor REVANCE THERAPEUTICS, INC. Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761127 Daxxify daxibotulinumtoxinA-lanm 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DAXXIFY daxibotulinumtoixnA-lanm INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 0.1ML 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DAXXIFY BOTULINUM TOXIN TYPE A Revance Therapeutics, Inc. 3aaa6e14-a3f7-4fb2-b9f9-d3a9c3ae1f74 2026-01-07 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761127 ndc (product): 72960-112
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 72960-112 DAXXIFY botulinum toxin type A Revance Therapeutics, Inc. BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 75081 SUPPL 2023-08-16 75080 SUPPL 2023-08-16 75061 SUPPL 2023-08-14 72258 ORIG 2022-10-06 72051 ORIG 2022-09-09 72050 ORIG 2022-09-09 72047 ORIG 2022-09-08