Treats HIV-1 infection. NDA 20779, held by Agouron Pharms. Nelfinavir Mesylate.
As of Nov 13, 2026, NDA 20779 (Viracept), held by Agouron Pharms, was first approved by FDA on Mar 14, 1997, with 55 approved supplements and 0 published complete response letters.
VIRACEPT in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection. VIRACEPT is a protease inhibitor indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 19, 2004 | Supplement 42Efficacy (new indication or use) · Priority review | Approved | |
| May 17, 2000 | Supplement 26Efficacy (new indication or use) · Standard review | Approved | |
| Nov 24, 1999 | Supplement 22Efficacy (new indication or use) · Standard review | Approved | |
| Mar 14, 1997 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ViraceptEQ 250MG BASE · tablet;oral | Nelfinavir Mesylate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 24, 2021 | Supplement 63Labeling · Standard review | Approved | |
| Sep 15, 2016 | Supplement 62Labeling | Approved | |
| Mar 27, 2015 | Supplement 61Labeling | Approved | |
| May 28, 2013 | Supplement 59Labeling · Standard review | Approved | |
| Apr 6, 2012 | Supplement 57Labeling · Standard review | Approved | |
| Feb 17, 2012 | Supplement 58Labeling | Approved | |
| Feb 25, 2011 | Supplement 56Labeling · Standard review | Approved | |
| Apr 26, 2010 | Supplement 54Labeling | Approved | |
| Apr 26, 2010 | Supplement 55Labeling | Approved | |
| Nov 25, 2008 | Supplement 53Labeling · Standard review | Approved | |
| Feb 13, 2008 | Supplement 50Labeling · Standard review | Approved | |
| Jul 31, 2007 | Supplement 48Labeling · Standard review | Approved | |
| Dec 22, 2006 | Supplement 46Labeling · Standard review | Approved | |
| Sep 28, 2005 | Supplement 45Labeling · Standard review | Approved | |
| Jun 4, 2004 | Supplement 44Labeling · Standard review | Approved | |
| Mar 19, 2004 | Supplement 42Efficacy (new indication or use) · Priority review | Approved | |
| Aug 27, 2003 | Supplement 41Labeling · Standard review | Approved | |
| Dec 20, 2002 | Supplement 39Labeling · Standard review | Approved | |
| Feb 5, 2002 | Supplement 37Manufacturing · Priority review | Approved | |
| Feb 5, 2002 | Supplement 38Labeling · Standard review | Approved | |
| Oct 26, 2001 | Supplement 35Manufacturing · Priority review | Approved | |
| Oct 26, 2001 | Supplement 36Manufacturing · Priority review | Approved | |
| Sep 28, 2001 | Supplement 34Manufacturing · Priority review | Approved | None posted |
| Jun 19, 2001 | Supplement 33Manufacturing · Priority review | Approved | None posted |
| Apr 5, 2001 | Supplement 32Labeling · Standard review | Approved | |
| Nov 8, 2000 | Supplement 31Manufacturing · Priority review | Approved | None posted |
| Sep 15, 2000 | Supplement 30Manufacturing · Priority review | Approved | None posted |
| May 17, 2000 | Supplement 26Efficacy (new indication or use) · Standard review | Approved | |
| Mar 28, 2000 | Supplement 29Labeling · Standard review | Approved | None posted |
| Feb 7, 2000 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| Nov 24, 1999 | Supplement 22Efficacy (new indication or use) · Standard review | Approved | |
| Nov 24, 1999 | Supplement 27Manufacturing · Priority review | Approved | None posted |
| Aug 17, 1999 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Aug 6, 1999 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Jul 16, 1999 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| May 25, 1999 | Supplement 20Labeling · Standard review | Approved | |
| Mar 19, 1999 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Dec 1, 1998 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Oct 30, 1998 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Sep 14, 1998 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Jul 17, 1998 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Jun 12, 1998 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Jun 5, 1998 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| May 4, 1998 | Supplement 11Manufacturing · Priority review | Approved | |
| May 4, 1998 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Feb 3, 1998 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Nov 26, 1997 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Nov 21, 1997 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Nov 21, 1997 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Sep 30, 1997 | Supplement 7Labeling · Standard review | Approved | None posted |
| Aug 29, 1997 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Aug 29, 1997 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1997 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jun 16, 1997 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Jun 4, 1997 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Mar 14, 1997 | Original applicationNew molecular entity · 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
