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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
  
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