Treats HIV-1 infection. NDA 21356, held by Gilead Sciences Inc. Tenofovir Disoproxil Fumarate.
As of Nov 14, 2026, NDA 21356 (Viread), held by Gilead Sciences Inc, was first approved by FDA on Oct 26, 2001, with 35 approved supplements and 0 published complete response letters.
VIREAD is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. for the treatment of chronic hepatitis B in adults and pediatric patients 2 years and older weighing at least 10 kg. 1.1 HIV-1 Infection VIREAD is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. 1.
| Dec 11, 2018 | Supplement 57Efficacy (new indication or use) · Priority review | Approved | |
| May 29, 2015 | Supplement 49Efficacy (new indication or use) · Standard review | Approved | |
| Jul 24, 2013 | Supplement 46Efficacy (new indication or use) · Standard review | Approved | |
| Aug 16, 2012 | Supplement 42Efficacy (new indication or use) · Priority review | Approved | |
| Aug 7, 2012 | Supplement 40Efficacy (new indication or use) · Standard review | Approved | |
| Jan 18, 2012 | Supplement 38Efficacy (new indication or use) · Priority review | Approved | |
| Sep 19, 2011 | Supplement 37Efficacy (new indication or use) · Standard review | Approved | |
| Oct 14, 2010 | Supplement 35Efficacy (new indication or use) · Standard review | Approved | |
| Oct 1, 2010 | Supplement 34Efficacy (new indication or use) · Standard review | Approved | |
| Mar 24, 2010 | Supplement 33Efficacy (new indication or use) · Priority review | Approved | |
| Oct 7, 2009 | Supplement 27Efficacy (new indication or use) · Standard review | Approved | |
| Aug 11, 2008 | Supplement 25Efficacy (new indication or use) · Standard review | Approved | |
| May 16, 2008 | Supplement 24Efficacy (new indication or use) | Approved | |
| Mar 8, 2006 | Supplement 16Efficacy (new indication or use) | Approved | |
| May 12, 2005 | Supplement 11Efficacy (new indication or use) | Approved | |
| Aug 15, 2003 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Oct 26, 2001 | Original applicationNew molecular entity · Priority review | Approved |
| Viread300MG · tablet;oral | Tenofovir Disoproxil Fumarate | RxReference drug |
| Viread150MG · tablet;oral | Tenofovir Disoproxil Fumarate | RxReference drug |
| Viread200MG · tablet;oral | Tenofovir Disoproxil Fumarate | RxReference drug |
| Viread250MG · tablet;oral | Tenofovir Disoproxil Fumarate | RxReference drug |
| Apr 24, 2019 | Supplement 58Labeling · Standard review | Approved | |
| Dec 11, 2018 | Supplement 57Efficacy (new indication or use) · Priority review | Approved | |
| Jul 30, 2018 | Supplement 56Labeling · Standard review | Approved | |
| Apr 7, 2017 | Supplement 55Labeling · Standard review | Approved | |
| Mar 10, 2016 | Supplement 53Manufacturing · Priority review | Approved | None posted |
| Feb 16, 2016 | Supplement 52Labeling · Standard review | Approved | |
| Nov 18, 2015 | Supplement 51Manufacturing · Priority review | Approved | None posted |
| May 29, 2015 | Supplement 49Efficacy (new indication or use) · Standard review | Approved | |
| Oct 23, 2013 | Supplement 48Labeling | Approved | |
| Jul 24, 2013 | Supplement 46Efficacy (new indication or use) · Standard review | Approved | |
| Apr 2, 2013 | Supplement 47Labeling · Standard review | Approved | |
| Mar 12, 2013 | Supplement 45Manufacturing · Priority review | Approved | None posted |
| Aug 16, 2012 | Supplement 42Efficacy (new indication or use) · Priority review | Approved | |
| Aug 7, 2012 | Supplement 40Efficacy (new indication or use) · Standard review | Approved | |
| Jan 18, 2012 | Supplement 38Efficacy (new indication or use) · Priority review | Approved | |
| Nov 18, 2011 | Supplement 41Labeling | Approved | |
| Sep 19, 2011 | Supplement 37Efficacy (new indication or use) · Standard review | Approved | |
| Oct 14, 2010 | Supplement 35Efficacy (new indication or use) · Standard review | Approved | |
| Oct 1, 2010 | Supplement 34Efficacy (new indication or use) · Standard review | Approved | |
| Mar 24, 2010 | Supplement 33Efficacy (new indication or use) · Priority review | Approved | |
| Jan 15, 2010 | Supplement 32Labeling · Standard review | Approved | None posted |
| Nov 10, 2009 | Supplement 28Labeling · Standard review | Approved | |
| Oct 7, 2009 | Supplement 27Efficacy (new indication or use) · Standard review | Approved | |
| Nov 4, 2008 | Supplement 26Labeling · Standard review | Approved | |
| Aug 11, 2008 | Supplement 25Efficacy (new indication or use) · Standard review | Approved | |
| May 16, 2008 | Supplement 24Efficacy (new indication or use) | Approved | |
| May 21, 2007 | Supplement 21Labeling · Standard review | Approved | |
| Mar 8, 2006 | Supplement 16Efficacy (new indication or use) | Approved | |
| Nov 30, 2005 | Supplement 17Labeling · Standard review | Approved | |
| May 12, 2005 | Supplement 11Efficacy (new indication or use) | Approved | |
| Jul 1, 2004 | Supplement 10Labeling · Standard review | Approved | |
| Oct 31, 2003 | Supplement 6Labeling · Standard review | Approved | |
| Oct 14, 2003 | Supplement 5Labeling · Standard review | Approved | |
| Aug 15, 2003 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Dec 2, 2002 | Supplement 1Labeling · Standard review | Approved | |
| Oct 26, 2001 | 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
