Details for New Drug Application (NDA): 090844
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The generic ingredient in CLOPIDOGREL BISULFATE is clopidogrel bisulfate. There are fifty-four drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the clopidogrel bisulfate profile page.
Summary for 090844
Tradename: | CLOPIDOGREL BISULFATE |
Applicant: | Torrent Pharms Ltd |
Ingredient: | clopidogrel bisulfate |
Patents: | 0 |
Pharmacology for NDA: 090844
Mechanism of Action | Cytochrome P450 2C8 Inhibitors P2Y12 Receptor Antagonists |
Physiological Effect | Decreased Platelet Aggregation |
Suppliers and Packaging for NDA: 090844
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 090844 | ANDA | Major Pharmaceuticals | 0904-6294 | 0904-6294-61 | 100 BLISTER PACK in 1 CARTON (0904-6294-61) / 1 TABLET in 1 BLISTER PACK |
CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 090844 | ANDA | Torrent Pharmaceuticals Limited | 13668-141 | 13668-141-01 | 100 TABLET in 1 BOTTLE (13668-141-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 75MG BASE | ||||
Approval Date: | May 17, 2012 | TE: | AB | RLD: | No |
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