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FDA NDA · NDA021713

ABILIFY

Sponsor: OTSUKA

APPLICATION
NDA021713
TYPE
NDA
ORIGINAL APPROVAL
2004-12-10
LATEST ACTION
2020-02-05
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

ABILIFY · ReferenceDiscontinued
ARIPIPRAZOLE 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL

Approval history

2020-02-05Labeling · Supplement 35 · standard — Letter ↗AP
2020-02-05Labeling · Supplement 36 · 901 required — Letter ↗AP
2019-08-07Labeling · Supplement 34 · standard — Letter ↗AP
2017-02-23Labeling · Supplement 33 · 901 required — Label ↗AP
2016-08-18Labeling · Supplement 32 · 901 required — Label ↗AP
2016-01-15Labeling · Supplement 31 · standard — Letter ↗AP
2014-12-12Efficacy · Supplement 30 · standard — Letter ↗AP
2014-06-09Efficacy · Supplement 28 · standard — Pediatric Medical Review ↗AP
2013-07-30Labeling · Supplement 29 · standard — Label ↗AP
2012-02-22Labeling · Supplement 25 · unknown — Letter ↗AP
2011-03-02Labeling · Supplement 24 · unknown — Letter ↗AP
2011-02-16Efficacy · Supplement 21 · standard — Label ↗AP
2010-12-01Labeling · Supplement 23 · 901 required — Letter ↗AP
2010-11-30Labeling · Supplement 22 · unknown — Letter ↗AP
2009-07-19Labeling · Supplement 20 · 901 required — Letter ↗AP
2008-08-14Labeling · Supplement 19 · standard — Label ↗AP
2008-05-06Labeling · Supplement 17 · standard — Review ↗AP
2008-05-06Efficacy · Supplement 15 · unknown — Review ↗AP
2008-05-06Efficacy · Supplement 14 · unknown — Review ↗AP
2008-03-06Labeling · Supplement 18 · standard — Letter ↗AP
2008-02-27Efficacy · Supplement 16 · priority — Letter ↗AP
2007-11-16Efficacy · Supplement 13 · unknown — Label ↗AP
2007-10-29Efficacy · Supplement 12 · unknown — Label ↗AP
2007-09-25Labeling · Supplement 10 · standard — Label ↗AP
2006-10-20Labeling · Supplement 8 · standard — Label ↗AP
2006-09-18Labeling · Supplement 9 · standard — Label ↗AP
2006-02-16Labeling · Supplement 6 · standard — Letter ↗AP
2005-06-21Labeling · Supplement 4 · standard — Letter ↗AP
2005-03-01Efficacy · Supplement 3 · unknown — Letter ↗AP
2004-12-10Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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