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Last Updated: June 4, 2023

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-three suppliers are listed for this compound. Additional details are available on the clopidogrel bisulfate profile page.
Summary for 020839
Applicant:Sanofi Aventis Us
Ingredient:clopidogrel bisulfate
Formulation / Manufacturing:see details
Pharmacology for NDA: 020839
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:RXDosage:TABLET;ORALStrengthEQ 75MG BASE
Approval Date:Nov 17, 1997TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Sep 20, 2007TE:ABRLD:Yes

Expired US Patents for NDA 020839

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts

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