Details for New Drug Application (NDA): 078004
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NDA 078004 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, 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-five NDAs. It is available from forty-three 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-four 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-four suppliers are listed for this compound. Additional details are available on the clopidogrel bisulfate profile page.
Summary for 078004
| Tradename: | CLOPIDOGREL BISULFATE |
| Applicant: | Acme Labs |
| Ingredient: | clopidogrel bisulfate |
| Patents: | 0 |
Pharmacology for NDA: 078004
| Mechanism of Action | Cytochrome P450 2C8 Inhibitors P2Y12 Receptor Antagonists |
| Physiological Effect | Decreased Platelet Aggregation |
Suppliers and Packaging for NDA: 078004
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 078004 | ANDA | ACI Healthcare USA, Inc | 71093-142 | 71093-142-04 | 90 TABLET, FILM COATED in 1 BOTTLE (71093-142-04) |
| CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 078004 | ANDA | ACI Healthcare USA, Inc | 71093-142 | 71093-142-05 | 500 TABLET, FILM COATED in 1 BOTTLE (71093-142-05) |
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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