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FDA NDA · NDA021866

ABILIFY

Sponsor: OTSUKA

APPLICATION
NDA021866
TYPE
NDA
ORIGINAL APPROVAL
2006-09-20
LATEST ACTION
2020-02-05
ROUTE
INTRAMUSCULAR
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ABILIFYDiscontinued
ARIPIPRAZOLE 9.75MG/1.3ML (7.5MG/ML) · INJECTABLE · INTRAMUSCULAR

Approval history

2020-02-05Labeling · Supplement 30 · 901 required — Letter ↗AP
2020-02-05Labeling · Supplement 29 · standard — Letter ↗AP
2019-08-07Labeling · Supplement 28 · standard — Letter ↗AP
2017-02-23Labeling · Supplement 27 · 901 required — Label ↗AP
2016-08-18Labeling · Supplement 26 · 901 required — Label ↗AP
2016-01-15Labeling · Supplement 25 · standard — Label ↗AP
2015-02-03Manufacturing (CMC) · Supplement 24 · standardAP
2014-12-12Efficacy · Supplement 23 · standard — Letter ↗AP
2014-06-09Efficacy · Supplement 21 · standard — Pediatric Medical Review ↗AP
2013-07-30Labeling · Supplement 22 · standard — Label ↗AP
2012-02-22Labeling · Supplement 20 · unknown — Letter ↗AP
2011-03-02Labeling · Supplement 19 · unknown — Label ↗AP
2011-02-16Efficacy · Supplement 16 · standard — Label ↗AP
2010-12-01Labeling · Supplement 18 · 901 required — Label ↗AP
2010-11-30Labeling · Supplement 17 · unknown — Label ↗AP
2010-02-03Labeling · Supplement 15 · unknown — Letter ↗AP
2009-07-19Labeling · Supplement 14 · 901 required — Label ↗AP
2008-08-14Labeling · Supplement 13 · standard — Letter ↗AP
2008-05-06Efficacy · Supplement 6 · unknown — Review ↗AP
2008-05-06Labeling · Supplement 9 · standard — Review ↗AP
2008-05-06Efficacy · Supplement 7 · unknown — Summary Review ↗AP
2008-03-06Labeling · Supplement 10 · standard — Letter ↗AP
2008-02-27Efficacy · Supplement 8 · priority — Letter ↗AP
2007-11-16Efficacy · Supplement 5 · unknown — Letter ↗AP
2007-10-29Efficacy · Supplement 4 · unknown — Letter ↗AP
2007-09-25Labeling · Supplement 2 · standard — Label ↗AP
2007-09-25Labeling · Supplement 3 · standard — Label ↗AP
2006-09-20Type 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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