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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
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