NDA 21729, held by Otsuka. Aripiprazole.
As of Nov 15, 2026, NDA 21729 (Abilify), held by Otsuka, was first approved by FDA on Jun 7, 2006, with 25 approved supplements and 0 published complete response letters.
| Dec 12, 2014 | Supplement 22Efficacy (new indication or use) · Standard review | Approved | |
| Jun 9, 2014 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Feb 16, 2011 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| May 6, 2008 | Supplement 7Efficacy (new indication or use) | Approved | |
| May 6, 2008 | Supplement 6Efficacy (new indication or use) | Approved | |
| Feb 27, 2008 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Nov 16, 2007 | Supplement 5Efficacy (new indication or use) | Approved | |
| Oct 29, 2007 | Supplement 4Efficacy (new indication or use) | Approved | |
| Jun 7, 2006 | Original applicationNew dosage form · Standard review | Approved |
| Abilify10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral | Aripiprazole | DiscontinuedReference drug |
| Abilify15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral | Aripiprazole | DiscontinuedReference drug |
| Abilify20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral | Aripiprazole | DiscontinuedReference drug |
| Abilify30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral | Aripiprazole | DiscontinuedReference drug |
| Feb 5, 2020 | Supplement 28Labeling | Approved | |
| Feb 5, 2020 | Supplement 27Labeling · Standard review | Approved | |
| Aug 7, 2019 | Supplement 26Labeling · Standard review | Approved | |
| Feb 23, 2017 | Supplement 25Labeling | Approved | |
| Aug 18, 2016 | Supplement 24Labeling | Approved | |
| Jan 15, 2016 | Supplement 23Labeling · Standard review | Approved | |
| Dec 12, 2014 | Supplement 22Efficacy (new indication or use) · Standard review | Approved | |
| Jun 9, 2014 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Jul 30, 2013 | Supplement 21Labeling · Standard review | Approved | |
| Feb 22, 2012 | Supplement 18Labeling | Approved | |
| Mar 2, 2011 | Supplement 17Labeling | Approved | |
| Feb 16, 2011 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Dec 1, 2010 | Supplement 16Labeling | Approved | |
| Nov 30, 2010 | Supplement 15Labeling | Approved | |
| Jul 19, 2009 | Supplement 13Labeling | Approved | |
| Aug 14, 2008 | Supplement 12Labeling · Standard review | Approved | |
| May 6, 2008 | Supplement 9Labeling · Standard review | Approved | |
| May 6, 2008 | Supplement 7Efficacy (new indication or use) | Approved | |
| May 6, 2008 | Supplement 6Efficacy (new indication or use) | Approved | |
| Mar 6, 2008 | Supplement 10Labeling · Standard review | Approved | |
| Feb 27, 2008 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Nov 16, 2007 | Supplement 5Efficacy (new indication or use) | Approved | |
| Oct 29, 2007 | Supplement 4Efficacy (new indication or use) | Approved | |
| Sep 25, 2007 | Supplement 2Labeling · Standard review | Approved | |
| Oct 20, 2006 | Supplement 1Labeling · Standard review | Approved | |
| Jun 7, 2006 | Original applicationNew dosage form · 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
