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FDA NDA · NDA210951

ERLEADA

apalutamide

Sponsor: JANSSEN BIOTECH

APPLICATION
NDA210951
TYPE
NDA
ORIGINAL APPROVAL
2018-02-14
LATEST ACTION
2026-06-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ERLEADA · ReferencePrescription
APALUTAMIDE 60MG · TABLET · ORAL
ERLEADA · ReferencePrescription
APALUTAMIDE 240MG · TABLET · ORAL

Approval history

2026-06-29Labeling · Supplement 24 · standard — Letter ↗AP
2026-03-05Labeling · Supplement 21 · standard — Letter ↗AP
2024-08-02Labeling · Supplement 16 · standard — Letter ↗AP
2024-07-09Manufacturing (CMC) · Supplement 17 — Letter ↗AP
2023-12-19Efficacy · Supplement 14 · standard — Letter ↗AP
2023-02-17Labeling · Supplement 11 · standard — Letter ↗AP
2022-11-08Labeling · Supplement 9 · standard — Letter ↗AP
2022-11-08Labeling · Supplement 10 · standard — Letter ↗AP
2022-04-26Labeling · Supplement 7 · standard — Label ↗AP
2021-09-07Efficacy · Supplement 6 · standard — Letter ↗AP
2021-07-14Labeling · Supplement 5 · standard — Letter ↗AP
2020-11-20Efficacy · Supplement 4 · priority — Label ↗AP
2020-09-01Labeling · Supplement 3 · standard — Letter ↗AP
2020-07-10Labeling · Supplement 2 · standard — Letter ↗AP
2019-09-17Efficacy · Supplement 1 · priority — Label ↗AP
2018-02-14Type 1 - New Molecular Entity · Original · priority — 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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