Treats HIV-1 infection. NDA 21896, held by Gilead. Emtricitabine.
As of Nov 14, 2026, NDA 21896 (Emtriva), held by Gilead, was first approved by FDA on Sep 28, 2005, with 10 approved supplements and 0 published complete response letters.
EMTRIVA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
| May 16, 2008 | Supplement 5Efficacy (new indication or use) | Approved | |
| Dec 22, 2006 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Sep 28, 2005 | Original applicationNew dosage form · Priority review | Approved |
| Emtriva10MG/ML · solution;oral | Emtricitabine | RxReference drug |
| Emtriva10MG/ML · solution; oral | Emtricitabine | Rx |
| Dec 10, 2018 | Supplement 26Labeling · Standard review | Approved | |
| Apr 7, 2017 | Supplement 25Labeling · Standard review | Approved | |
| Feb 20, 2014 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Nov 8, 2013 | Supplement 20Manufacturing · Priority review | Approved | None posted |
| Apr 2, 2013 | Supplement 18Labeling · Standard review | Approved | |
| Jul 23, 2012 | Supplement 16Labeling · Standard review | Approved | |
| Nov 18, 2011 | Supplement 15Labeling | Approved | |
| May 16, 2008 | Supplement 5Efficacy (new indication or use) | Approved | |
| Apr 4, 2008 | Supplement 4Labeling · Standard review | Approved | |
| Dec 22, 2006 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Sep 28, 2005 | 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
