XIAFLEX

Endo Pharmaceuticals Inc.🇺🇸 United States

FDA Page

Effective Date: Apr 22, 2026
Approval ID: 805cecd0-fd1f-11dd-87af-0800200c9a66
Products: 1 registered
Version: 46

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

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

Quick Stats

Total Products1

Labelers3

Label Sections40

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.