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FDA NDA · NDA021436

ABILIFY

aripiprazole

Sponsor: OTSUKA

APPLICATION
NDA021436
TYPE
NDA
ORIGINAL APPROVAL
2002-11-15
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ABILIFY · ReferencePrescription
ARIPIPRAZOLE 2MG · TABLET · ORAL
ABILIFY · ReferencePrescription
ARIPIPRAZOLE 30MG · TABLET · ORAL
ABILIFY · ReferencePrescription
ARIPIPRAZOLE 15MG · TABLET · ORAL
ABILIFY · ReferencePrescription
ARIPIPRAZOLE 5MG · TABLET · ORAL
ABILIFY · ReferencePrescription
ARIPIPRAZOLE 20MG · TABLET · ORAL
ABILIFY · ReferencePrescription
ARIPIPRAZOLE 10MG · TABLET · ORAL

Approval history

2025-01-22Labeling · Supplement 49 · standardAP
2025-01-22Labeling · Supplement 46 · standardLabelAP
2025-01-22Labeling · Supplement 50 · standardLabelAP
2022-11-30Labeling · Supplement 48 · standardLetterAP
2020-02-05Labeling · Supplement 45 · 901 requiredLetterAP
2020-02-05Labeling · Supplement 44 · standardLetterAP
2019-08-07Labeling · Supplement 43 · standardLetterAP
2017-02-23Labeling · Supplement 42 · 901 requiredLabelAP
2016-08-18Labeling · Supplement 41 · 901 requiredLabelAP
2016-01-15Labeling · Supplement 40 · standardLabelAP
2014-12-15Manufacturing (CMC) · Supplement 39 · standardAP
2014-12-12Efficacy · Supplement 38 · standardReviewAP
2014-06-09Efficacy · Supplement 36 · standardPediatric Statistical ReviewAP
2013-07-30Labeling · Supplement 37 · standardLabelAP
2013-03-25Manufacturing (CMC) · Supplement 35 · standardAP
2012-02-22Labeling · Supplement 34 · unknownLetterAP
2011-03-02Labeling · Supplement 32 · unknownLetterAP
2011-02-16Efficacy · Supplement 29 · standardLetterAP
2010-12-01Labeling · Supplement 31 · 901 requiredLabelAP
2010-11-30Labeling · Supplement 30 · unknownLabelAP
2009-11-19Efficacy · Supplement 27 · standardReviewAP
2009-07-19Labeling · Supplement 28 · 901 requiredLetterAP
2008-08-14Labeling · Supplement 26 · standardLetterAP
2008-05-06Efficacy · Supplement 20 · unknownReviewAP
2008-05-06Efficacy · Supplement 19 · standardReviewAP
2008-05-06Labeling · Supplement 22 · standardReviewAP
2008-03-06Labeling · Supplement 23 · standardLetterAP
2008-02-27Efficacy · Supplement 21 · priorityPediatric Written RequestAP
2007-11-16Efficacy · Supplement 18 · priorityLabelAP
2007-10-29Efficacy · Supplement 17 · priorityLabelAP
2007-09-25Labeling · Supplement 16 · standardLabelAP
2006-10-20Labeling · Supplement 13 · standardLetterAP
2006-09-18Labeling · Supplement 14 · standardLabelAP
2006-02-16Labeling · Supplement 10 · standardLetterAP
2005-06-21Labeling · Supplement 7 · standardReviewAP
2005-03-01Efficacy · Supplement 5 · unknownLabelAP
2005-03-01Labeling · Supplement 8 · standardLabelAP
2004-09-29Efficacy · Supplement 2 · standardLabelAP
2004-04-08Labeling · Supplement 6 · standardLetterAP
2003-12-30Supplement · Supplement 4 · standardReviewAP
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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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