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FDA NDA · NDA213674

XTANDI

enzalutamide

Sponsor: ASTELLAS

APPLICATION
NDA213674
TYPE
NDA
ORIGINAL APPROVAL
2020-08-04
LATEST ACTION
2026-07-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

XTANDI · ReferencePrescription
ENZALUTAMIDE 80MG · TABLET · ORAL
XTANDI · ReferencePrescription
ENZALUTAMIDE 40MG · TABLET · ORAL

Approval history

2026-07-24Efficacy · Supplement 16 · standard — Label ↗AP
2025-12-11Labeling · Supplement 15 · standard — Letter ↗AP
2025-03-21Labeling · Supplement 12 · standard — Label ↗AP
2025-01-22Labeling · Supplement 11 · standard — Label ↗AP
2023-11-16Efficacy · Supplement 10 · priority — Label ↗AP
2022-09-09Efficacy · Supplement 6 · standard — Letter ↗AP
2022-01-13Labeling · Supplement 5 · standard — Letter ↗AP
2021-05-24Labeling · Supplement 2 · standard — Label ↗AP
2020-08-04Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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