Details for New Drug Application (NDA): 213351
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NDA 213351 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 thirty-eight 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-nine 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-nine suppliers are listed for this compound. Additional details are available on the clopidogrel bisulfate profile page.
Summary for 213351
| Tradename: | CLOPIDOGREL BISULFATE |
| Applicant: | Polygen Pharms |
| Ingredient: | clopidogrel bisulfate |
| Patents: | 0 |
Pharmacology for NDA: 213351
| Mechanism of Action | Cytochrome P450 2C8 Inhibitors P2Y12 Receptor Antagonists |
| Physiological Effect | Decreased Platelet Aggregation |
Suppliers and Packaging for NDA: 213351
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 213351 | ANDA | POLYGEN PHARMACEUTICALS INC. | 52605-082 | 52605-082-10 | 1000 TABLET in 1 BOTTLE, DISPENSING (52605-082-10) |
| CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 213351 | ANDA | POLYGEN PHARMACEUTICALS INC. | 52605-082 | 52605-082-13 | 30 TABLET in 1 BOTTLE (52605-082-13) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | Jul 17, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 300MG BASE | ||||
| Approval Date: | Jul 17, 2020 | TE: | AB | RLD: | No | ||||
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