NDA 20933, held by Boehringer Ingelheim. Nevirapine.
As of Nov 13, 2026, NDA 20933 (Viramune), held by Boehringer Ingelheim, was first approved by FDA on Sep 11, 1998, with 29 approved supplements and 0 published complete response letters.
| Jun 24, 2008 | Supplement 17Efficacy (new indication or use) · Priority review | Approved | |
| Mar 27, 2002 | Supplement 7Efficacy (new indication or use) | Approved | |
| Sep 11, 1998 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Viramune50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · suspension;oral | Nevirapine | DiscontinuedReference drug |
| Jul 22, 2024 | Supplement 48Labeling · Standard review | Approved | |
| Jun 10, 2022 | Supplement 43Labeling · Standard review | Approved | |
| Sep 24, 2018 | Supplement 40Labeling · Standard review | Approved | |
| Mar 27, 2017 | Supplement 38Labeling · Standard review | Approved | |
| Feb 3, 2015 | Supplement 37Manufacturing | Approved | None posted |
| Jan 27, 2014 | Supplement 35Labeling · Standard review | Approved | |
| Feb 8, 2013 | Supplement 34Manufacturing | Approved | None posted |
| Nov 9, 2012 | Supplement 33Labeling · Standard review | Approved | |
| Nov 9, 2011 | Supplement 30Labeling · Standard review | Approved | |
| May 6, 2011 | Supplement 29REMS | Approved | |
| Mar 25, 2011 | Supplement 28Labeling · Standard review | Approved | |
| Jan 7, 2011 | Supplement 27REMS | Approved | |
| Jul 20, 2010 | Supplement 26Labeling · Standard review | Approved | |
| Jan 13, 2010 | Supplement 22Labeling · Standard review | Approved | |
| Jun 24, 2008 | Supplement 17Efficacy (new indication or use) · Priority review | Approved | |
| Aug 16, 2007 | Supplement 19Labeling · Standard review | Approved | |
| Apr 13, 2007 | Supplement 15Labeling · Standard review | Approved | |
| Feb 24, 2005 | Supplement 14Labeling · Standard review | Approved | |
| May 24, 2004 | Supplement 12Labeling · Standard review | Approved | None posted |
| Dec 22, 2003 | Supplement 11Labeling · Standard review | Approved | |
| Jul 29, 2003 | Supplement 10Labeling · Standard review | Approved | |
| Dec 31, 2002 | Supplement 6Labeling · Standard review | Approved | |
| Dec 20, 2002 | Supplement 9Manufacturing | Approved | None posted |
| Mar 27, 2002 | Supplement 7Efficacy (new indication or use) | Approved | |
| May 17, 2001 | Supplement 4Manufacturing | Approved | None posted |
| Feb 23, 2001 | Supplement 5Manufacturing | Approved | None posted |
| Nov 6, 2000 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 10, 2000 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 25, 1999 | Supplement 1Labeling · Standard review | Approved | None posted |
| Sep 11, 1998 | Original applicationNew dosage form · Priority 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
