NDA 21866, held by Otsuka. Aripiprazole.
As of Nov 14, 2026, NDA 21866 (Abilify), held by Otsuka, was first approved by FDA on Sep 20, 2006, with 27 approved supplements and 0 published complete response letters.
| Dec 12, 2014 | Supplement 23Efficacy (new indication or use) · Standard review | Approved | |
| Jun 9, 2014 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Feb 16, 2011 | Supplement 16Efficacy (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 | |
| Sep 20, 2006 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Abilify9.75MG/1.3ML (7.5MG/ML) · injectable;intramuscular | Aripiprazole | Discontinued |
| Feb 5, 2020 | Supplement 30Labeling | Approved | |
| Feb 5, 2020 | Supplement 29Labeling · Standard review | Approved | |
| Aug 7, 2019 | Supplement 28Labeling · Standard review | Approved | |
| Feb 23, 2017 | Supplement 27Labeling | Approved | |
| Aug 18, 2016 | Supplement 26Labeling | Approved | |
| Jan 15, 2016 | Supplement 25Labeling · Standard review | Approved | |
| Feb 3, 2015 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Dec 12, 2014 | Supplement 23Efficacy (new indication or use) · Standard review | Approved | |
| Jun 9, 2014 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Jul 30, 2013 | Supplement 22Labeling · Standard review | Approved | |
| Feb 22, 2012 | Supplement 20Labeling | Approved | |
| Mar 2, 2011 | Supplement 19Labeling | Approved | |
| Feb 16, 2011 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Dec 1, 2010 | Supplement 18Labeling | Approved | |
| Nov 30, 2010 | Supplement 17Labeling | Approved | |
| Feb 3, 2010 | Supplement 15Labeling | Approved | |
| Jul 19, 2009 | Supplement 14Labeling | Approved | |
| Aug 14, 2008 | Supplement 13Labeling · 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 3Labeling · Standard review | Approved | |
| Sep 25, 2007 | Supplement 2Labeling · Standard review | Approved | |
| Sep 20, 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
