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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 eleven 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-three drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the clopidogrel bisulfate profile page.

Summary for NDA: 020839

Tradename:
PLAVIX
Applicant:
Sanofi Aventis Us
Ingredient:
clopidogrel bisulfate
Patents:2
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:see details

Pharmacology for NDA: 020839

Mechanism of ActionP2Y12 Receptor Antagonists
Physiological EffectDecreased 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 STAT RX USA LLC 16590-288 16590-288-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16590-288-30)
PLAVIX
clopidogrel bisulfate
TABLET;ORAL 020839 NDA STAT RX USA LLC 16590-288 16590-288-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16590-288-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 75MG BASE
Approval Date:Nov 17, 1997TE:ABRLD:No
Patent:6,429,210*PEDPatent Expiration:Dec 10, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:6,504,030*PEDPatent Expiration:Dec 10, 2019Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Sep 20, 2007TE:ABRLD:Yes
Patent:6,429,210*PEDPatent Expiration:Dec 10, 2019Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 020839

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
PLAVIX
clopidogrel bisulfate
TABLET;ORAL020839-001Nov 17, 19974,529,596► subscribe
Sanofi Aventis Us
PLAVIX
clopidogrel bisulfate
TABLET;ORAL020839-002Sep 20, 20074,847,265*PED► subscribe
Sanofi Aventis Us
PLAVIX
clopidogrel bisulfate
TABLET;ORAL020839-001Nov 17, 19975,576,328*PED► subscribe
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