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… Plavix (clopidogrel bisulfate) Tablets, Sanofi-Synthelabo NDA 20-839/S21 & S24 9/29/03 10/9/03 Plavix (clopidogrel bisulfate) Tablets, Sanofi-Synthelabo NDA 20-839/S-019 2/27/02 3/7/02 5/16/02 5/16/02 | Plavix Indication: (New) for patients with acute coronary syndrome (unstable angina/non-Q-wave MI), including patients who are to be managed medically and those who are to be managed with percutaneous coronary intervention (with or without stent) or CABG, PLAVIX has been shown to decrease the rate of a combined endpoint of cardiovascular death, MI, or stroke as sell as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia. | Plavix (clopidogrel bisulfate) Tablets, Sanofi-Synthelabo NDA 20-839/S-018 | Plavix (clopidogrel bisulfate) Tablets, Sanofi-Synthelabo, Labeling Revision | Plavix (clopidogrel bisulfate) Tablets, Sanofi-Synthelabo, Labeling Revision | Plavix (clopidogrel bisulfate) Tablets, Sanofi-Aventis, Labeling Revision | Clopidogrel Bisulfate Tablets, Apotex, Approval | Plavix (clopidogrel bisulfate) 75 mg Tablets, Sanofi-Aventis, Labeling Revision | Plavix (clopidogrel bisulfate) Tablets, Sanofi-Aventis, New or Modified Indication | Plavix (clopidogrel bisulfate) Tablets, Sanofi-Aventis, Labeling Revision | Clopidogrel Bisulfate Tablets, Roxane Labs, Tentative Approval | Clopidogrel Tablets, Mutual Pharma, Tentative Approval | Clopidogrel Tablets, Dr. Reddy’s Labs, Approval | Plavix (clopidogrel bisulfate) Tablets, Sanofi-Aventis U.S. Inc., Labeling Revision | Plavix (clopidogrel bisulfate) Tablets, Sanofi Aventis, Labeling Revision | Plavix (clopidogrel bisulfate) Tablets, Sanofi-aventis, Labeling Revision | Clopidogrel Tablets, Torrent Pharmaceuticals Limited, Tentative Approval | Clopidogrel Bisulfate Tablets, Mylan Pharmaceuticals Inc., Tentative Approval | Clopidogrel Tablets, Dr. Reddy’s Laboratories, Ltd., Tentative Approval | Plavix (clopidogrel bisulfate) Tablets, Sanofi-Aventis, Labeling Revision | Plavix (clopidogrel bisulfate) Tablets, sanofi-aventis U.S., LLC, Efficacy Supplement with Clinical Data to Support | Plavix (clopidogrel bisulfate) Tablets, sanofi-aventis U.S. LLC, Supplement | Clopidogrel Tablets, Sun Pharma Global, Tentative Approval | Plavix, clopidogrel bisulfate, Tablet; Oral, Sanofi Aventis Us, 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