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… Zerit XR (stavudine) Extended-Release Capsules, 37.5 mg, 50 mg, 75 mg, and 100 mg, Bristol-Myers Squibb Company NDA 21-453 12/31/02 1/30/03 4/9/03 | ZERIT (stavudine) Capsules and Pediatric Solution (POS). Bristol-Myers Squibb Company NDA 20-412/S15 10/16/01 4/22/03 | ZERIT (stavudine) Capsules and Pediatric Solution (POS), Bristol-Myers Squibb Company NDA 20-412/S16 & 20-413/S7 3/29/02 4/8/02 3/29/02 | ZERIT (stavudine) Capsules and Pediatric Solution (POS). Bristol-Myers Squibb Company NDA 20-412/S17, S18 & 20-413/S8, S9 2/20/02 2/21/02 | ZERIT (stavudine) for Solution Bristol-Myers Squibb Company NDA 20-413/S6 Zerit (stavudine) Capsules, Bristol-Myers Squibb | | Zerit (stavudine) Powder for Oral Solution, Bristol-Myers Squibb | | Zerit XR Extended-Release, (stavudine) Capsules Bristol-Myers Squibb | ZERIT (stavudine) extended release capsules, Bristol-Myers Squibb, Labeling Revision | Stavudine Capsules, Aurobindo Pharma Limited, Tentative Approval | Stavudine Capsules, Aurobindo Pharma, Tentative Approval | Stavudine Capsules, Aurobindo Pharma, Tentative Approval | Stavudine Capsules, Strides Arcolab, Tentative Approval | Lamivudine, Stavudine, Nevirapine Tablets, Cipla Ltd., Tentative Approval | Stavudine/Lamivudine Tablets Co-packaged with Nevirapine Tablets, Strides Arcolab, Tentative Approval | Stavudine/Lamivudine Tablets, Strides Arcolab, Tentative Approval | Stavudine Capsules, Matrix Labs, Tentative Approval | Zerit (stavudine) Capsules, Bristol-Myers Squibb, Labeling Revision | Zerit (stavudine) Powder Oral Solution, Bristol-Myers Squibb, Labeling Revision | Stavudine/Lamivudine Tablets Co-packaged w/Efavirenz Tablets, Strides, Tentative Approval | Zerit (stavudine) Powder for Oral Solution, Bristol-Myers Squibb, Labeling Revision | Zerit (stavudine) Capsules, Bristol-Myers Squibb, Labeling Revision | Zerit (stavudine) Powder for Oral Solution, Bristol-Myers Squibb, Labeling Revision | Zerit (stavudine) Capsules, Bristol-Myers Squibb, Labeling Revision | Zerit (stavudine) Powder Oral Solution, Bristol-Myers Squibb, Labeling Revision | Lamivudine/Stavudine/Nevirapine Dispersible Tablets, Cipla Ltd., Tentative Approval | Stavudine Oral Solution, Cipla Ltd., Tentative Approval | Lamivudine/Stavudine Tablets, Matrix Labs, Tentative Approval | Stavudine Capsules, Emcure Pharma, Tentative Approval | Stavudine Capsules, InvaGen Pharma, Tentative Approval | Stavudine/Lamivudine/Nevirapine Tablets, Strides Arcolab, Tentative Approval | Zerit (stavudine) Capsules, Bristol-Myers Squibb, Labeling Revision | Zerit (stavudine) For Oral Solution, Bristol-Myers Squibb, Control Supplement | Zerit (stavudine) For Oral Solution, Bristol-Myers Squibb, Labeling Revision | Stavudine Oral Solution, Aurobindo Pharma USA, Inc., Tentative Approval | Lamivudine/Stavudine Tablets, Cipla Ltd., Tentative Approval | Stavudine Capsules, Aurobindo Pharma USA, Inc., Tentative Approval | Zerit (stavudine) Capsules, Bristol-Myers Squibb Company, Labeling Revision | Zerit (stavudine) Oral Solution, Bristol-Myers Squibb Company, Labeling Revision | Stavudine Capsules, Hetero Drugs Ltd., Approval | Stavudine Capsules, Matrix Laboratories, Inc., Approval | Stavudine Capsules, Aurobindo Pharma Ltd., Approval | Stavudine Oral Solution, Aurobindo Pharma Ltd., Approval | Stavudine Capsules, Matrix Laboratories, Ltd., Approval | Zerit (stavudine) Capsules, Bristol-Myers Squibb Co., Labeling Revision | Zerit (stavudine) Oral Solution, Bristol-Myers Squibb Co., Labeling Revision | Stavudine, Lamivudine and Nevirapine Tablets, Pharmacare Ltd., Tentative Approval | Stavudine Oral Solution, Cipla Ltd., Approval | Zerit (stavudine) Capsules, Bristol-Myers Squibb Co., Labeling Revision | Zerit (stavudine) Oral Solution, Bristol-Myers Squibb Co., Labeling Revision | Stavudine, Lamivudine, and Nevirapine Tablets, Emcure Pharmaceuticals, Ltd., Tentative Approval | Lamivudine and Stavudine Tablets, Hetero Drugs Ltd., Tentative Approval | Lamivudine, Nevirapine, and Stavudine Tablets, Macleods Pharmaceuticals Ltd., Tentative Approval | Zerit (stavudine) Capsules, Bristol-Myers Squibb Co., Labeling Revision | Zerit (stavudine) Oral Solution, Bristol-Myers Squibb Co., Labeling Revision | Zerit (stavudine) Capsules, Bristol-Myers Squibb, Labeling Revision | Zerit (stavudine) Oral Solution, Bristol-Myers Squibb, 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 | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com