Details for New Drug Application (NDA): 201686
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NDA 201686 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, Polygen Pharms, Prinston Inc, Rising, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Industries, Teva, Torrent Pharms Ltd, and Zydus Lifesciences, and is included in twenty-four NDAs. It is available from forty-one 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. Forty-two 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. Forty-two suppliers are listed for this compound. Additional details are available on the clopidogrel bisulfate profile page.
Summary for 201686
| Tradename: | CLOPIDOGREL BISULFATE |
| Applicant: | Zydus Lifesciences |
| Ingredient: | clopidogrel bisulfate |
| Patents: | 0 |
Pharmacology for NDA: 201686
| Mechanism of Action | Cytochrome P450 2C8 Inhibitors P2Y12 Receptor Antagonists |
| Physiological Effect | Decreased Platelet Aggregation |
Suppliers and Packaging for NDA: 201686
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 201686 | ANDA | Zydus Lifesciences Limited | 70771-1062 | 70771-1062-0 | 1000 TABLET, FILM COATED in 1 BOTTLE (70771-1062-0) |
| CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 201686 | ANDA | Zydus Lifesciences Limited | 70771-1062 | 70771-1062-3 | 30 TABLET, FILM COATED in 1 BOTTLE (70771-1062-3) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | Oct 10, 2012 | TE: | RLD: | No | |||||
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