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Details for New Drug Application (NDA): 020839
NDA 020839 describes PLAVIX, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. 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-nine 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-nine 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 |
| 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 | PD-Rx Pharmaceuticals, Inc. | 55289-911 | 55289-911-15 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-911-15) |
| PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839 | NDA | PD-Rx Pharmaceuticals, Inc. | 55289-911 | 55289-911-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-911-30) |
Paragraph IV (Patent) Challenges for 020839
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| PLAVIX | TABLET;ORAL | clopidogrel bisulfate | 020839 | 2009-03-04 |
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 | ||||
| Patent: | Start Trial | Patent Expiration: | Dec 10, 2019 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | Start Trial | Patent Expiration: | Dec 10, 2019 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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: | Start Trial | 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 | 020839-001 | Nov 17, 1997 | Start Trial | Start Trial |
| Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-002 | Sep 20, 2007 | Start Trial | Start Trial |
| Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-001 | Nov 17, 1997 | Start Trial | Start Trial |
| Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-001 | Nov 17, 1997 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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