Xtandi

Astellas Pharma US, Inc.🇺🇸 United States

FDA Page

Effective Date: Jul 28, 2026
Approval ID: b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf
Products: 5 registered
Version: 24

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use XTANDI safely and effectively. See full prescribing information for XTANDI. XTANDI (enzalutamide) capsules, for oral useXTANDI (enzalutamide) tablets, for oral useInitial U.S. Approval: 2012

Quick Stats

Total Products5

Labelers2

Label Sections22

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.