Details for New Drug Application (NDA): 020839
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NDA 020839 describes PLAVIX, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from one supplier. Additional details are available on the PLAVIX profile page.
The generic ingredient in PLAVIX 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 PLAVIX 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 020839
| Tradename: | PLAVIX |
| Applicant: | Sanofi Aventis Us |
| Ingredient: | clopidogrel bisulfate |
| Patents: | 0 |
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 | 020839-001 | Nov 17, 1997 | 6,504,030*PED | ⤷ Subscribe |
| Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-001 | Nov 17, 1997 | 4,529,596 | ⤷ Subscribe |
| Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-002 | Sep 20, 2007 | 6,429,210*PED | ⤷ Subscribe |
| Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-002 | Sep 20, 2007 | 4,847,265*PED | ⤷ Subscribe |
| Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-001 | Nov 17, 1997 | 6,429,210*PED | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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