Treats Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive. NDA 21436, held by Otsuka. Aripiprazole.
As of Nov 15, 2026, NDA 21436 (Abilify), held by Otsuka, was first approved by FDA on Nov 15, 2002, with 41 approved supplements and 0 published complete response letters.
ABILIFY (aripiprazole) Tablets are indicated for the treatment of: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive Treatment of Major Depressive Disorder Irritability Associated with Autistic Disorder Treatment of Tourette's Disorder ABILIFY is an atypical antipsychotic. ABILIFY is indicated for: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive Treatment of Major Depressive Disorder Irritability Associated with Autistic Disorder Treatment of Tourette's Disorder
| Dec 12, 2014 | Supplement 38Efficacy (new indication or use) · Standard review | Approved | |
| Jun 9, 2014 | Supplement 36Efficacy (new indication or use) · Standard review | Approved | |
| Feb 16, 2011 | Supplement 29Efficacy (new indication or use) · Standard review | Approved | |
| Nov 19, 2009 | Supplement 27Efficacy (new indication or use) · Standard review | Approved | |
| May 6, 2008 | Supplement 20Efficacy (new indication or use) | Approved | |
| May 6, 2008 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Feb 27, 2008 | Supplement 21Efficacy (new indication or use) · Priority review | Approved | |
| Nov 16, 2007 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| Oct 29, 2007 | Supplement 17Efficacy (new indication or use) · Priority review | Approved | |
| Mar 1, 2005 | Supplement 5Efficacy (new indication or use) | Approved | |
| Sep 29, 2004 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Aug 28, 2003 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Nov 15, 2002 | Original applicationNew molecular entity · Standard review | Approved |
| Abilify10MG · tablet;oral | Aripiprazole | RxReference drug |
| Abilify15MG · tablet;oral | Aripiprazole | RxReference drug |
| Abilify20MG · tablet;oral | Aripiprazole | RxReference drug |
| Abilify30MG · tablet;oral | Aripiprazole | RxReference drug |
| Abilify5MG · tablet;oral | Aripiprazole | RxReference drug |
| Abilify2MG · tablet;oral | Aripiprazole | RxReference drug |
| Jan 22, 2025 | Supplement 46Labeling · Standard review | Approved | |
| Jan 22, 2025 | Supplement 49Labeling · Standard review | Approved | None posted |
| Jan 22, 2025 | Supplement 50Labeling · Standard review | Approved | |
| Nov 30, 2022 | Supplement 48Labeling · Standard review | Approved | |
| Feb 5, 2020 | Supplement 44Labeling · Standard review | Approved | |
| Feb 5, 2020 | Supplement 45Labeling | Approved | |
| Aug 7, 2019 | Supplement 43Labeling · Standard review | Approved | |
| Feb 23, 2017 | Supplement 42Labeling | Approved | |
| Aug 18, 2016 | Supplement 41Labeling | Approved | |
| Jan 15, 2016 | Supplement 40Labeling · Standard review | Approved | |
| Dec 15, 2014 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Dec 12, 2014 | Supplement 38Efficacy (new indication or use) · Standard review | Approved | |
| Jun 9, 2014 | Supplement 36Efficacy (new indication or use) · Standard review | Approved | |
| Jul 30, 2013 | Supplement 37Labeling · Standard review | Approved | |
| Mar 25, 2013 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Feb 22, 2012 | Supplement 34Labeling | Approved | |
| Mar 2, 2011 | Supplement 32Labeling | Approved | |
| Feb 16, 2011 | Supplement 29Efficacy (new indication or use) · Standard review | Approved | |
| Dec 1, 2010 | Supplement 31Labeling | Approved | |
| Nov 30, 2010 | Supplement 30Labeling | Approved | |
| Nov 19, 2009 | Supplement 27Efficacy (new indication or use) · Standard review | Approved | |
| Jul 19, 2009 | Supplement 28Labeling | Approved | |
| Aug 14, 2008 | Supplement 26Labeling · Standard review | Approved | |
| May 6, 2008 | Supplement 22Labeling · Standard review | Approved | |
| May 6, 2008 | Supplement 20Efficacy (new indication or use) | Approved | |
| May 6, 2008 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Mar 6, 2008 | Supplement 23Labeling · Standard review | Approved | |
| Feb 27, 2008 | Supplement 21Efficacy (new indication or use) · Priority review | Approved | |
| Nov 16, 2007 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| Oct 29, 2007 | Supplement 17Efficacy (new indication or use) · Priority review | Approved | |
| Sep 25, 2007 | Supplement 16Labeling · Standard review | Approved | |
| Oct 20, 2006 | Supplement 13Labeling · Standard review | Approved | |
| Sep 18, 2006 | Supplement 14Labeling · Standard review | Approved | |
| Feb 16, 2006 | Supplement 10Labeling · Standard review | Approved | |
| Jun 21, 2005 | Supplement 7Labeling · Standard review | Approved | |
| Mar 1, 2005 | Supplement 8Labeling · Standard review | Approved | |
| Mar 1, 2005 | Supplement 5Efficacy (new indication or use) | Approved | |
| Sep 29, 2004 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Apr 8, 2004 | Supplement 6Labeling · Standard review | Approved | |
| Dec 30, 2003 | Supplement 4 | Approved | |
| Aug 28, 2003 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Nov 15, 2002 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
