Home Applications 761192 Application 761192
Type BLA
Sponsor MEDIWOUND, LTD Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761192 Nexobrid anacaulase-bcdb 351(a) Disc 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NEXOBRID ANACAULASE-BCDB GEL;TOPICAL 8.8% 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 NEXOBRID ANACAULASE-BCDB Vericel Corporation 1a2f23ad-78ef-43fa-9864-6bd77aac9e57 2025-09-11 Warnings, Adverse reactions Exact identifier application number: BLA761192
Documents# Document, Submission type, Date table Document Submission type Date 79431 SUPPL 2024-08-16 79411 SUPPL 2024-08-16 73377 ORIG 2023-02-03 73078 ORIG 2023-01-04 73077 ORIG 2022-12-29