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FDA NDA · NDA202379

ZYTIGA

abiraterone acetate

Sponsor: JANSSEN BIOTECH

APPLICATION
NDA202379
TYPE
NDA
ORIGINAL APPROVAL
2011-04-28
LATEST ACTION
2021-08-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ZYTIGA · ReferencePrescription
ABIRATERONE ACETATE 500MG · TABLET · ORAL
ZYTIGA · ReferencePrescription
ABIRATERONE ACETATE 250MG · TABLET · ORAL

Approval history

2021-08-23Labeling · Supplement 35 · standard — Letter ↗AP
2020-10-02Labeling · Supplement 33 · standard — Letter ↗AP
2020-10-02Labeling · Supplement 31 · standard — Letter ↗AP
2019-06-03Efficacy · Supplement 28 · standard — Label ↗AP
2019-06-03Labeling · Supplement 27 · standard — Label ↗AP
2018-09-25Labeling · Supplement 25 · standard — Label ↗AP
2018-02-07Efficacy · Supplement 24 · priority — Letter ↗AP
2016-05-17Labeling · Supplement 23 · standard — Letter ↗AP
2015-12-10Labeling · Supplement 21 · standard — Label ↗AP
2015-08-18Manufacturing (CMC) · Supplement 20 · priorityAP
2015-05-20Labeling · Supplement 18 · standard — Letter ↗AP
2015-03-20Efficacy · Supplement 16 · standard — Label ↗AP
2015-03-03Manufacturing (CMC) · Supplement 17 · priorityAP
2015-01-23Labeling · Supplement 15 · standard — Label ↗AP
2015-01-20Manufacturing (CMC) · Supplement 14 · priorityAP
2014-11-16Manufacturing (CMC) · Supplement 13 · priorityAP
2014-05-13Labeling · Supplement 9 · standard — Letter ↗AP
2014-04-17Manufacturing (CMC) · Supplement 11 · priorityAP
2014-04-01Manufacturing (CMC) · Supplement 10 · priorityAP
2014-02-07Manufacturing (CMC) · Supplement 8 · priorityAP
2013-09-12Labeling · Supplement 7 · standard — Review ↗AP
2013-06-17Manufacturing (CMC) · Supplement 6 · priority — Review ↗AP
2012-12-10Efficacy · Supplement 5 · priority — Review ↗AP
2012-09-17Labeling · Supplement 4 · standard — Label ↗AP
2012-07-03Labeling · Supplement 3 · standard — Label ↗AP
2011-04-28Type 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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