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 five 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. Fifty-eight 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	Rebel Distributors Corp	21695-665	21695-665-30	30 TABLET, FILM COATED in 1 BOTTLE (21695-665-30)
PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839	NDA	Rebel Distributors Corp	21695-665	21695-665-90	90 TABLET, FILM COATED in 1 BOTTLE (21695-665-90)

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:	➤ Try a Free Trial	Patent Expiration:	Dec 10, 2019	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	➤ Try a Free 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:	➤ Try a Free Trial	Patent Expiration:	Dec 10, 2019	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 020839

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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	➤ Try a Free Trial	➤ Try a Free Trial
Sanofi Aventis Us	PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839-002	Sep 20, 2007	➤ Try a Free Trial	➤ Try a Free Trial
Sanofi Aventis Us	PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839-001	Nov 17, 1997	➤ Try a Free Trial	➤ Try a Free Trial
Sanofi Aventis Us	PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839-001	Nov 17, 1997	➤ Try a Free Trial	➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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