NDA 21713, held by Otsuka. Aripiprazole.
As of Nov 14, 2026, NDA 21713 (Abilify), held by Otsuka, was first approved by FDA on Dec 10, 2004, with 29 approved supplements and 0 published complete response letters.
| Dec 12, 2014 | Supplement 30Efficacy (new indication or use) · Standard review | Approved | |
| Jun 9, 2014 | Supplement 28Efficacy (new indication or use) · Standard review | Approved | |
| Feb 16, 2011 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| May 6, 2008 | Supplement 15Efficacy (new indication or use) | Approved | |
| May 6, 2008 | Supplement 14Efficacy (new indication or use) | Approved | |
| Feb 27, 2008 | Supplement 16Efficacy (new indication or use) · Priority review | Approved | |
| Nov 16, 2007 | Supplement 13Efficacy (new indication or use) | Approved | |
| Oct 29, 2007 | Supplement 12Efficacy (new indication or use) | Approved | |
| Mar 1, 2005 | Supplement 3Efficacy (new indication or use) | Approved | |
| Dec 10, 2004 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Abilify1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;oral | Aripiprazole | DiscontinuedReference drug |
| Feb 5, 2020 | Supplement 36Labeling | Approved | |
| Feb 5, 2020 | Supplement 35Labeling · Standard review | Approved | |
| Aug 7, 2019 | Supplement 34Labeling · Standard review | Approved | |
| Feb 23, 2017 | Supplement 33Labeling | Approved | |
| Aug 18, 2016 | Supplement 32Labeling | Approved | |
| Jan 15, 2016 | Supplement 31Labeling · Standard review | Approved | |
| Dec 12, 2014 | Supplement 30Efficacy (new indication or use) · Standard review | Approved | |
| Jun 9, 2014 | Supplement 28Efficacy (new indication or use) · Standard review | Approved | |
| Jul 30, 2013 | Supplement 29Labeling · Standard review | Approved | |
| Feb 22, 2012 | Supplement 25Labeling | Approved | |
| Mar 2, 2011 | Supplement 24Labeling | Approved | |
| Feb 16, 2011 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Dec 1, 2010 | Supplement 23Labeling | Approved | |
| Nov 30, 2010 | Supplement 22Labeling | Approved | |
| Jul 19, 2009 | Supplement 20Labeling | Approved | |
| Aug 14, 2008 | Supplement 19Labeling · Standard review | Approved | |
| May 6, 2008 | Supplement 17Labeling · Standard review | Approved | |
| May 6, 2008 | Supplement 15Efficacy (new indication or use) | Approved | |
| May 6, 2008 | Supplement 14Efficacy (new indication or use) | Approved | |
| Mar 6, 2008 | Supplement 18Labeling · Standard review | Approved | |
| Feb 27, 2008 | Supplement 16Efficacy (new indication or use) · Priority review | Approved | |
| Nov 16, 2007 | Supplement 13Efficacy (new indication or use) | Approved | |
| Oct 29, 2007 | Supplement 12Efficacy (new indication or use) | Approved | |
| Sep 25, 2007 | Supplement 10Labeling · Standard review | Approved | |
| Oct 20, 2006 | Supplement 8Labeling · Standard review | Approved | |
| Sep 18, 2006 | Supplement 9Labeling · Standard review | Approved | |
| Feb 16, 2006 | Supplement 6Labeling · Standard review | Approved | |
| Jun 21, 2005 | Supplement 4Labeling · Standard review | Approved | |
| Mar 1, 2005 | Supplement 3Efficacy (new indication or use) | Approved | |
| Dec 10, 2004 | 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
