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… Sustiva (Efavirenz) Tablets & Capsules, 600 mg and 50, 100 & 200 mg respectively, Bristol-Myers Squibb NDA 20-972/S-18 & 21-360/S-3 6/10/03 7/8/03 7/8/03 | Sustiva (Efavirenz) Tablets & Capsules, 600 mg and 50, 100 & 200 mg respectively, Bristol-Myers Squibb NDA 20-972/S-19 & 21-360/S-4 6/10/03 7/8/03 7/8/03 | Sustiva (Efavirenz) Tablets & Capsules, 300 & 600 mg and 50, 100 & 200 mg respectively, Bristol-Myers Squibb NDA 20-972/S-17 & 21-360/S-1 9/20/02 9/27/02 | Sustiva (Efavirenz) Tablets, 300 & 600 mg, Bristol-Myers Squibb Pharma Company NDA 21-360 2/1/02 2/27/02 2/4/02 5/15/02 | Sustiva (efavirenz) Capsules, 50, 100 & 200 mg, Bristol-Myers Squibb Company NDA 20-972/S-016 1/29/03 2/12/03 2/13/03 | Sustiva (efavirenz) Capsules, 50, 100 & 200 mg, DuPont Company NDA 20-972/S13 10/16/01 04/25/03 | Sustiva (efavirenz), Bristol-Myers Squibb Company NDA 20-972/S-007 3/1/02 3/5/02 | Sustiva (efavirenz), 50mg, 100mg, 200mg capsules (Group Leader Memo) (Divison Director Memo) DuPont Company NDA 20-972 9/17/98 9/24/98 9/17/98 12/10 | Sustiva (efavirenz), 50 mg, 100 mg, and 200 mg capsules DuPont Company NDA 20-972/SE7-001 2/9/00 2/14/00 | Sustiva Indication:For the treatment of HIV-1 infection Sustiva (Efavirenz) Capsules & Tablets, Bristol-Myers Squibb | SUSTIVA (efavirenz) Capsules, Bristol-Myers Squibb, Efficacy Supplement with Clinical Data to Support | SUSTIVA (efavirenz) Tablets, Bristol-Myers Squibb, Efficacy Supplement with Clinical Data to Support | Sustiva (efavirenz) tablets, GlaxoSmithKline, Labeling Revision | Sustiva (efavirenz) capsules, GlaxoSmithKline, Labeling Revision | SUSTIVA (efavirenz) Capsules, Bristol-Myers Squibb, Labeling Revision | SUSTIVA (efavirenz) Tablets, Bristol-Myers Squibb, Labeling Revision | Efavirenz Tablets, Aurobindo Pharma, Tentative Approval | Sustiva (efavirenz) capsules, Bristol-Myers Squibb, Labeling Revision | Sustiva (efavirenz) tablets, Bristol-Myers Squibb, Labeling Revision | Efavirenz Tablets, Cipla, Tentative Approval | Efavirenz Capsules, Aurobindo Pharma, Tentative Approval | Sustiva (efavirenz) Capsules, Bristol-Myers Squibb, Labeling Revision | Sustiva (efavirenz) Tablets, Bristol-Myers Squibb, Labeling Revision | Efavirenz Tablets, Strides Inc., Tentative Approval | Efavirenz Tablets, Matrix Labs, Tentative Approval | Efavirenz, Tablet, Emcure, Tentative Approval | ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Labeling Revision | Efavirenz Tablets, Hetero Drugs Ltd, Tentative Approval | Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Efficacy Supplement with Clinical Data to Support | Sustiva (efavirenz) Capsules, Bristol-Myers Squibb Co., Labeling Revision | Sustiva (efavirenz) Tablets, Bristol-Myers Squibb Co., Labeling Revision | Efavirenz Tablets, Aurobindo Pharma Ltd., Tentative Approval | Sustiva (efavirenz) Capsules, Bristol-Myers Squibb Co., Labeling Revision | Sustiva (efavirenz) Tablets, Bristol-Myers Squibb Co., Labeling Revision | Efavirenz Capsules, Cipla Ltd., Tentative Approval | Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, Laboratories Ltd., Tentative Approval | Sustiva (efavirenz) Capsules, Bristol-Myers Squibb Company, Labeling Revision | Sustiva (efavirenz) Tablets, Bristol-Myers Squibb Company, Labeling Revision | Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Efficacy Supplement with Clinical Data to Support | Sustiva (efavirenz) Tablets, Bristol-Myers Squibb Co., Labeling Revision | Sustiva (efavirenz) Capsules, Bristol-Myers Squibb Co., Labeling Revision | Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Labeling Revision | Sustiva (efavirenz) Capsules, Bristol Myers Squibb, Labeling Revision | Sustiva (efavirenz) Tablets, Bristol Myers Squibb, Labeling Revision | Efavirenz Tablets, Matrix Laboratories Ltd., Tentative Approval | Efavirenz Tablets, MacLeods Pharmaceuticals Ltd., Tentative Approval | Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Labeling Revision | Sustiva (efavirenz) Capsules, Bristol-Myers Squibb Co., Labeling Revision | Sustiva (efavirenz) Tablets, Bristol-Myers Squibb Co., Labeling Revision | Efavirenz, Emitricitabine and Tenofovir Disoproxil Fumarate Tablets, TEVA Pharmaceuticals, Tentative Approval | Sustiva, efavirenz, Capsule; Oral, Bristol Myers Squibb, Labeling Revision | Sustiva, efavirenz, Tablet; Oral, Bristol Myers Squibb, Labeling Revision | Efavirenz, efavirenz, Capsule; Oral, Micro Labs Ltd, Tentative Approval ^ 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 © 2012 Betterchem.com