NDA 21360, held by Bristol Myers Squibb. Efavirenz.
As of Nov 15, 2026, NDA 21360 (Sustiva), held by Bristol Myers Squibb, was first approved by FDA on Feb 1, 2002, with 33 approved supplements and 0 published complete response letters.
| May 2, 2013 | Supplement 31Efficacy (new indication or use) · Priority review | Approved | |
| Aug 13, 2004 | Supplement 6Efficacy (new indication or use) | Approved | |
| Feb 1, 2002 | Original applicationNew dosage form · Standard review | Approved |
| Sustiva300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Efavirenz | DiscontinuedReference drug |
| Sustiva600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Efavirenz | DiscontinuedReference drug |
| Nov 8, 2023 | Supplement 47Labeling · Standard review | Approved | |
| Oct 29, 2019 | Supplement 45Labeling · Standard review | Approved | |
| Oct 10, 2017 | Supplement 44Labeling · Standard review | Approved | |
| Jan 30, 2017 | Supplement 42Labeling · Standard review | Approved | |
| Oct 31, 2016 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Oct 12, 2016 | Supplement 41Labeling · Standard review | Approved | |
| Aug 31, 2016 | Supplement 39Labeling · Standard review | Approved | |
| Mar 31, 2016 | Supplement 38Labeling · Standard review | Approved | |
| Mar 27, 2015 | Supplement 37Labeling · Standard review | Approved | |
| Aug 14, 2014 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| May 23, 2014 | Supplement 35Labeling · Standard review | Approved | |
| Jan 22, 2014 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Jul 9, 2013 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| May 2, 2013 | Supplement 31Efficacy (new indication or use) · Priority review | Approved | |
| Aug 10, 2012 | Supplement 30Labeling | Approved | |
| Jun 22, 2012 | Supplement 29Labeling · Standard review | Approved | |
| Dec 19, 2011 | Supplement 28Labeling · Standard review | Approved | |
| Sep 26, 2011 | Supplement 26Labeling · Standard review | Approved | |
| Nov 30, 2010 | Supplement 24Labeling · Standard review | Approved | |
| Mar 31, 2010 | Supplement 23Labeling | Approved | |
| Sep 23, 2009 | Supplement 21Labeling · Standard review | Approved | |
| Mar 11, 2009 | Supplement 18Labeling · Standard review | Approved | |
| Aug 18, 2008 | Supplement 19Labeling · Standard review | Approved | |
| Aug 18, 2008 | Supplement 17Labeling · Standard review | Approved | |
| Jan 24, 2007 | Supplement 16Labeling · Standard review | Approved | |
| Mar 28, 2006 | Supplement 14Labeling · Standard review | Approved | |
| Apr 20, 2005 | Supplement 13Labeling · Standard review | Approved | |
| Oct 22, 2004 | Supplement 9Labeling · Standard review | Approved | |
| Aug 13, 2004 | Supplement 6Efficacy (new indication or use) | Approved | |
| Nov 13, 2003 | Supplement 5Labeling · Standard review | Approved | |
| Jun 10, 2003 | Supplement 4Labeling · Standard review | Approved | |
| Jun 10, 2003 | Supplement 3Labeling · Standard review | Approved | |
| Sep 20, 2002 | Supplement 1Labeling · Standard review | Approved | |
| Feb 1, 2002 | 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
