Home Applications 125338 Application 125338
Type BLA
Sponsor AUXILIUM PHARMS Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125338 Xiaflex collagenase clostridium histolyticum 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 XIAFLEX COLLAGENASE CLOSTRIDIUM HISTOLYTICUM SOLUTION; INJECTION 0.9MG 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 XIAFLEX COLLAGENASE CLOSTRIDIUM HISTOLYTICUM Endo USA, Inc. 805cecd0-fd1f-11dd-87af-0800200c9a66 2026-04-22 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125338 ndc (product): 66887-003
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 66887-003 XIAFLEX collagenase clostridium histolyticum Endo Pharmaceuticals Inc. BLA Current 66887-003 XIAFLEX collagenase clostridium histolyticum Endo Pharmaceuticals, Inc. BLA Current 66887-003 XIAFLEX collagenase clostridium histolyticum Endo Pharmaceuticals Inc. BLA Current 66887-003 XIAFLEX collagenase clostridium histolyticum Endo Pharmaceuticals Inc. BLA Current 66887-003 XIAFLEX collagenase clostridium histolyticum Endo Pharmaceuticals Inc. BLA Current 66887-003 XIAFLEX collagenase clostridium histolyticum Endo Pharmaceuticals Inc. BLA Current 66887-003 XIAFLEX collagenase clostridium histolyticum Endo Pharmaceuticals Inc. BLA Current 66887-003 XIAFLEX collagenase clostridium histolyticum Endo Pharmaceuticals Inc. BLA Current