Home Applications 761225 Application 761225
Type BLA
Sponsor HUGEL INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761225 Letybo letibotulinumtoxinA-wlbg 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LETYBO LETIBOTULINUMTOXINA-WLBG POWDER, FOR SOLUTION 0.1ML(4UNITS) 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 LETYBO LETIBOTULINUMTOXINA-WLBG Hugel, Inc. 910e5d0e-4d0b-4de8-8e2d-97879a044181 2024-11-18 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761225
Documents# Document, Submission type, Date table Document Submission type Date 77925 ORIG 2024-03-25 77687 ORIG 2024-03-01 77678 ORIG 2024-03-01 77677 ORIG 2024-03-01