Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Safety Information For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

FDA Approval Activities for this Drug… Emtriva (emtricitabine) Capsules, 200 mg Gilead Sciences, NDA 21-500 Truvada, (emtricitabine (200 mg) and tenofovir disoproxil fumarate (300 mg)) tablets, Gilead Sciences, Approval | Truvada (emtricitabine/tenofovir DF) Tablets, Gilead Sciences, Labeling Revision | Emtriva (emtricitabine) Capsules, Gilead Sciences, Labeling Revision | Truvada (emtricitabine/tenofovir DF) Tablets, Gilead Sciences, Labeling Revision | EMTRIVA (emtricitabine) Capsules, Gilead Sciences, Labeling Revision | TRUVADA Tablets, Gilead Sciences, Accelerated Approval | EMTRIVA (emtricitabine) Oral Solution, Gilead Sciences, Patient Population Altered & Labeling Revision | Truvada (emtricitabine/tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Labeling Revision | ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Labeling Revision | Emtriva (emtricitabine) Capsules, Gilead Sciences, Labeling Revision | Emtriva (emtricitabine) Oral Solution, Gilead Sciences, Labeling Revision | Emtricitabine Capsules, Aurobindo Pharma USA, Inc., Tentative Approval | Emtriva (emtricitabine) Capsules, Gilead Sciences, Inc., Efficacy Supplement with Clinical Data to Support | Emtriva (emtricitabine) Oral Solution, Gilead Sciences, Inc., Efficacy Supplement with Clinical Data to Support | Truvada (emtricitabine and 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 | Truvada (emtricitabine and tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Labeling Revision | Emtricitabine Capsules, Matrix Laboratories Ltd., Approval | Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, Matrix Laboratories Ltd., Tentative Approval | Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, Laboratories Ltd., Tentative Approval | Truvada (emtricitabine and tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Labeling Revision | Atripla (efavirenz, emtricitabine and 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., Labeling Revision | Emtricitabine Capsules, Cipla Ltd., Tentative Approval | Truvada (emtricitabine and tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Labeling Revision | Complera (emtricitabine, rilpivirine and tenofovir disoproxil fumarate) Fixed Dose Combination Tablets, Gilead Sciences, Inc., Approval | Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Labeling Revision | Efavirenz, Emitricitabine and Tenofovir Disoproxil Fumarate Tablets, TEVA Pharmaceuticals, Tentative Approval | Emtriva (emtricitabine) Capsules, Gilead Sciences, Inc., Labeling Revision | Emtriva (emtricitabine) Oral Solution, Gilead Sciences, Inc., Labeling Revision | Emtricitabine; Tenofovir Disoproxil Fumarate, emtricitabine; tenofovir disoproxil fumarate, Tablet; Oral, Hetero Labs Unit Iii, Tentative Approval | Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate, efavirenz; emtricitabine; tenofovir disoproxil fumarate, Tablet; Oral, Cipla Limited, Tentative Approval | Atripla, efavirenz; emtricitabine; tenofovir disoproxil fumarate, Tablet; Oral, Gilead, Labeling Revision | Truvada, emtricitabine; tenofovir disoproxil fumarate, Tablet; Oral, Gilead, Labeling Revision | Truvada, emtricitabine; tenofovir disoproxil fumarate, Tablet; Oral, Gilead, New or Modified Indication | Emtriva, emtricitabine, Capsule; Oral, Gilead, Labeling Revision | Emtriva, emtricitabine, Solution; Oral, Gilead, Labeling Revision | Complera, emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate, Tablet; Oral, Gilead Sciences Inc, Labeling Revision | Stribild, cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate, Tablet; Oral, Gilead Sciences Inc, Manufacturing Change or Addition | Complera, emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate, Tablet; Oral, Gilead Sciences Inc, Manufacturing Change or Addition | Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate, efavirenz; emtricitabine; tenofovir disoproxil fumarate, Tablet; Oral, Aurobindo Pharma Ltd, Tentative Approval | Emtriva, emtricitabine, Capsule; Oral, Gilead, Labeling Revision | Emtriva, emtricitabine, Solution; Oral, Gilead, Labeling Revision | Atripla, efavirenz; emtricitabine; tenofovir disoproxil fumarate, Tablet; Oral, Gilead, Labeling Revision | Complera, emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate, Tablet; Oral, Gilead Sciences Inc, Manufacturing Change or Addition | Stribild, cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate, Tablet; Oral, Gilead Sciences Inc, Manufacturing Change or Addition | Complera, emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate, Tablet; Oral, Gilead Sciences Inc, Manufacturing Change or Addition ^ FDA's latest approval appears at the bottom of this list. ^                                                                       A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2013 Betterchem.com