Application Nr Approved Date Route Status External Links
ANDA077665 2012-05-17 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Clopidogrel Tablets, Usp Are A P2y 12 Platelet Inhibitor Indicated For: •acute Coronary Syndrome •for Patients With Non-St-Segment Elevation Acs [unstable Angina (ua)/non-St-Elevation Myocardial Infarction (nstemi)], Clopidogrel Tablets Have Been Shown To Decrease The Rate Of A Combined Endpoint Of Cardiovascular Death, Myocardial Infarction (mi), Or Stroke As Well As The Rate Of A Combined Endpoint Of Cardiovascular Death, Mi, Stroke, Or Refractory Ischemia. ( 1.1) •for Patients With St-Elevation Myocardial Infarction (stemi), Clopidogrel Tablets Have Been Shown To Reduce The Rate Of Death From Any Cause And The Rate Of A Combined Endpoint Of Death, Re-Infarction, Or Stroke. The Benefit For Patients Who Undergo Primary Pci Is Unknown. ( 1.1) •recent Mi, Recent Stroke, Or Established Peripheral Arterial Disease. Clopidogrel Tablets Have Been Shown To Reduce The Combined Endpoint Of New Ischemic Stroke, New Mi, And Other Vascular Death. ( 1.2) 1.1 Acute Coronary Syndrome (acs) •for Patients With Non-St-Segment Elevation Acs [unstable Angina (ua)/non-St- Elevation Myocardial Infarction (nstemi)], Including Patients Who Are To Be Managed Medically And Those Who Are To Be Managed With Coronary Revascularization, Clopidogrel Tablets, Usp Have Been Shown To Decrease The Rate Of A Combined Endpoint Of Cardiovascular Death, Myocardial Infarction (mi), Or Stroke As Well As The Rate Of A Combined Endpoint Of Cardiovascular Death, Mi, Stroke, Or Refractory Ischemia. •for Patients With St-Elevation Myocardial Infarction (stemi), Clopidogrel Tablets Have Been Shown To Reduce The Rate Of Death From Any Cause And The Rate Of A Combined Endpoint Of Death, Re-Infarction, Or Stroke. The Benefit For Patients Who Undergo Primary Percutaneous Coronary Intervention Is Unknown. The Optimal Duration Of Clopidogrel Therapy In Acs Is Unknown. 1.2 Recent Mi, Recent Stroke, Or Established Peripheral Arterial Disease For Patients With A History Of Recent Myocardial Infarction (mi), Recent Stroke, Or Established Peripheral Arterial Disease, Clopidogrel Tablets Have Been Shown To Reduce The Rate Of A Combined Endpoint Of New Ischemic Stroke (fatal Or Not), New Mi (fatal Or Not), And Other Vascular Death.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Hypromelloses HYPROMELLOSES Unresolved
4. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
7. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Clopidogrel Bisulfate CLOPIDOGREL BISULFATE ZINC34781704

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