MedPath
FDA Product

Xtandi

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Xtandi

0469-1725

Regulatory Information

0469-1725

NDA213674

C73594

November 20, 2023

USA

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

HUMAN PRESCRIPTION DRUG LABEL

19

Company Information

605764828

Active Ingredients

ENZALUTAMIDE

Quantity: 40 mg in 1 1

Code: 93T0T9GKNU

Class Code: ACTIB

Active Moieties

ENZALUTAMIDE

Code: 93T0T9GKNU

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