Details for New Drug Application (NDA): 020839
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The generic ingredient in PLAVIX is clopidogrel bisulfate. There are fifty-four drug master file entries for this compound. Forty-one 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: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020839
Mechanism of Action | Cytochrome P450 2C8 Inhibitors P2Y12 Receptor Antagonists |
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 | sanofi-aventis U.S. LLC | 0024-1171 | 0024-1171-90 | 90 TABLET, FILM COATED in 1 BOTTLE (0024-1171-90) |
PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839 | NDA | sanofi-aventis U.S. LLC | 0024-1332 | 0024-1332-30 | 3 BLISTER PACK in 1 CARTON (0024-1332-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 75MG BASE | ||||
Approval Date: | Nov 17, 1997 | TE: | AB | RLD: | Yes |
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 |
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 | 020839-002 | 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 | 020839-002 | 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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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