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XIAFLEX

These highlights do not include all the information needed to use XIAFLEX safely and effectively. See full prescribing information for XIAFLEX. XIAFLEX (collagenase clostridium histolyticum) for injection, for intralesional use Initial U.S. Approval: 2010

Approved
Approval ID

805cecd0-fd1f-11dd-87af-0800200c9a66

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 31, 2022

Manufacturers
FDA

Endo Pharmaceuticals Inc.

DUNS: 178074951

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

collagenase clostridium histolyticum

PRODUCT DETAILS

NDC Product Code66887-003
Application NumberBLA125338
Marketing CategoryC73585
Route of AdministrationN/A
Effective DateAugust 9, 2022
Generic Namecollagenase clostridium histolyticum

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XIAFLEX - FDA Drug Approval Details