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 Drug Recalls 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 ^ 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 | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com