Details for New Drug Application (NDA): 091023
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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 091023
Tradename: | CLOPIDOGREL BISULFATE |
Applicant: | Dr Reddys Labs Ltd |
Ingredient: | clopidogrel bisulfate |
Patents: | 0 |
Pharmacology for NDA: 091023
Mechanism of Action | Cytochrome P450 2C8 Inhibitors P2Y12 Receptor Antagonists |
Physiological Effect | Decreased Platelet Aggregation |
Suppliers and Packaging for NDA: 091023
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 091023 | ANDA | Dr.Reddy's Laboratories Limited | 55111-671 | 55111-671-01 | 100 TABLET, FILM COATED in 1 BOTTLE (55111-671-01) |
CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 091023 | ANDA | Dr.Reddy's Laboratories Limited | 55111-671 | 55111-671-05 | 500 TABLET, FILM COATED in 1 BOTTLE (55111-671-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 300MG BASE | ||||
Approval Date: | May 17, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 75MG BASE | ||||
Approval Date: | Aug 5, 2024 | TE: | AB | RLD: | No |
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