Details for New Drug Application (NDA): 215388
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NDA 215388 describes CLOPIDOGREL BISULFATE, which is a drug marketed by Accord Hlthcare, Acme Labs, Actavis Totowa, Alkem Labs Ltd, Amneal Pharms, Ani Pharms, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Macleods Pharms Ltd, MSN, Prinston Inc, Puracap Labs Blu, Rising, Sciegen Pharms, Sun Pharm, Sun Pharm Industries, Teva, Torrent Pharms Ltd, and Zydus Lifesciences, and is included in twenty-five NDAs. It is available from thirty-six suppliers. Additional details are available on the CLOPIDOGREL BISULFATE profile page.
The generic ingredient in CLOPIDOGREL BISULFATE is clopidogrel bisulfate. There are fifty-four drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the clopidogrel bisulfate profile page.
The generic ingredient in CLOPIDOGREL BISULFATE is clopidogrel bisulfate. There are fifty-four drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the clopidogrel bisulfate profile page.
Summary for 215388
| Tradename: | CLOPIDOGREL BISULFATE |
| Applicant: | Msn |
| Ingredient: | clopidogrel bisulfate |
| Patents: | 0 |
Pharmacology for NDA: 215388
| Mechanism of Action | Cytochrome P450 2C8 Inhibitors P2Y12 Receptor Antagonists |
| Physiological Effect | Decreased Platelet Aggregation |
Suppliers and Packaging for NDA: 215388
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 215388 | ANDA | Preferred Pharmaceuticals Inc. | 68788-4173 | 68788-4173-3 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-4173-3) |
| CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 215388 | ANDA | Preferred Pharmaceuticals Inc. | 68788-4173 | 68788-4173-6 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-4173-6) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | Sep 20, 2024 | TE: | AB | RLD: | No | ||||
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