← FDA DRUG APPROVALS

FDA NDA · NDA203415

XTANDI

enzalutamide

Sponsor: ASTELLAS

APPLICATION
NDA203415
TYPE
NDA
ORIGINAL APPROVAL
2012-08-31
LATEST ACTION
2026-07-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

XTANDI · ReferencePrescription
ENZALUTAMIDE 40MG · CAPSULE · ORAL

Approval history

2026-07-24Efficacy · Supplement 26 · standard — Label ↗AP
2025-12-11Labeling · Supplement 25 · standard — Letter ↗AP
2025-03-21Labeling · Supplement 24 · standard — Label ↗AP
2025-01-22Labeling · Supplement 23 · standard — Label ↗AP
2023-11-16Efficacy · Supplement 22 · priority — Label ↗AP
2022-09-09Efficacy · Supplement 19 · standard — Letter ↗AP
2022-01-13Labeling · Supplement 18 · standard — Letter ↗AP
2020-10-23Efficacy · Supplement 16 · priority — Letter ↗AP
2019-12-16Efficacy · Supplement 15 · priority — Label ↗AP
2018-07-13Efficacy · Supplement 14 · priority — Label ↗AP
2017-07-24Efficacy · Supplement 11 · standard — Label ↗AP
2016-10-20Efficacy · Supplement 9 · standard — Label ↗AP
2016-07-14Manufacturing (CMC) · Supplement 10 · priorityAP
2015-11-06Manufacturing (CMC) · Supplement 8 · priorityAP
2015-10-01Labeling · Supplement 7 · standard — Letter ↗AP
2015-08-05Labeling · Supplement 6 · standard — Label ↗AP
2015-07-21Efficacy · Supplement 5 · standard — Label ↗AP
2014-09-10Efficacy · Supplement 3 · priority — Label ↗AP
2014-05-23Manufacturing (CMC) · Supplement 2 · priorityAP
2013-03-19Manufacturing (CMC) · Supplement 1 · priority — Label ↗AP
2012-08-31Type 1 - New Molecular Entity · Original · priority — Review ↗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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