FDA Approval Activities for this Drug
VIREAD (tenofovir disoproxil fumarate) Tablets, 300 mg, Gilead Sciences, Inc NDA 21-356/S5 10/14/03 10/16/03 10/16/03
VIREAD (tenofovir disoproxil fumarate) Tablets, 300 mg, Gilead Sciences, Inc NDA 21-356/S3 8/15/03 8/28/03 8/28/03
VIREAD (tenofovir disoproxil fumarate) Tablets, 300 mg, Gilead Sciences, Inc NDA 21-356/S1 12/2/02 12/9/02 12/2/02
VIREAD (tenofovir disoproxil fumarate) Tablets, 300 mg Gilead Sciences, Inc NDA 21-356 10/26/01 11/2/01 11/2/01 1/14/02
VIREAD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. VIREAD (tenofovir disoproxil fumerate) 300 mg Tablets, Gilead Sciences, Inc., Labeling Revision Truvada, (emtricitabine (200 mg) and tenofovir disoproxil fumarate (300 mg)) tablets, Gilead Sciences, Approval | Truvada (emtricitabine/tenofovir DF) Tablets, Gilead Sciences, Labeling Revision | Viread (tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Efficacy Supplement w/Clinical Data | Truvada (emtricitabine/tenofovir DF) Tablets, Gilead Sciences, Labeling Revision | VIREAD (tenofovir disoproxil fumarate, TDF) Tablets, Gilead Sciences, Labeling Revision | TRUVADA Tablets, Gilead Sciences, Accelerated Approval | Truvada (emtricitabine/tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Labeling Revision | Viread (tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Labeling Revision | Tenofovir Disoproxil Fumarate Tablets, Matrix Labs, Tentative Approval | ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Labeling Revision | Truvada (emtricitabine and tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Efficacy Supplement with Clinical Data to Support| Viread (tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Efficacy Supplement with Clinical Data to Support | Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Efficacy Supplement with Clinical Data to Support | Viread (tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., New or Modified Indication | Lamivudine and Tenofovir Disoproxil Fumarate Tablets, Matrix Laboratories, Ltd., Tentative Approval | Truvada (emtricitabine and tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Labeling Revision | Viread (tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Labeling Revision