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Details for New Drug Application (NDA): 020839
The generic ingredient in PLAVIX is clopidogrel bisulfate. There are fifty-three drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the clopidogrel bisulfate profile page.
Summary for 020839
Tradename: | PLAVIX |
Applicant: | Sanofi Aventis Us |
Ingredient: | clopidogrel bisulfate |
Patents: | 2 |
Therapeutic Class: | Blood Products/Modifiers/ Volume Expanders |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020839
Mechanism of Action | P2Y12 Receptor Antagonists Cytochrome P450 2C8 Inhibitors |
Physiological Effect | Decreased Platelet Aggregation |
Suppliers and Packaging for NDA: 020839
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839 | NDA | Rebel Distributors Corp | 21695-665 | E | 21695-665-30 |
PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839 | NDA | Rebel Distributors Corp | 21695-665 | E | 21695-665-90 |
Profile for product number 001
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 300MG BASE | ||||
Approval Date: | Sep 20, 2007 | TE: | AB | RLD: | Yes | ||||
Patent: | ➤ Sign Up | Patent Expiration: | Dec 10, 2019 | Product Flag? | Substance Flag? | Delist Request? | Y |
Expired US Patents for NDA 020839
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-002 | Sep 20, 2007 | ➤ Sign Up | ➤ Sign Up |
Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-001 | Nov 17, 1997 | ➤ Sign Up | ➤ Sign Up |
Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-001 | Nov 17, 1997 | ➤ Sign Up | ➤ Sign Up |
Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-001 | Nov 17, 1997 | ➤ Sign Up | ➤ Sign Up |
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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