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Last Updated: July 10, 2020

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Details for New Drug Application (NDA): 020757


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NDA 020757 describes AVAPRO, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from four suppliers. Additional details are available on the AVAPRO profile page.

The generic ingredient in AVAPRO is irbesartan. There are thirty-eight drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the irbesartan profile page.
Summary for 020757
Tradename:AVAPRO
Applicant:Sanofi Aventis Us
Ingredient:irbesartan
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020757
Suppliers and Packaging for NDA: 020757
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AVAPRO irbesartan TABLET;ORAL 020757 NDA Sanofi-Aventis U.S. LLC 0024-5850 0024-5850-90 90 TABLET, FILM COATED in 1 BOTTLE (0024-5850-90)
AVAPRO irbesartan TABLET;ORAL 020757 NDA Sanofi-Aventis U.S. LLC 0024-5851 0024-5851-30 30 TABLET, FILM COATED in 1 BOTTLE (0024-5851-30)
Paragraph IV (Patent) Challenges for 020757
Tradename Dosage Ingredient NDA Submissiondate
AVAPRO TABLET;ORAL irbesartan 020757 2004-05-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength75MG
Approval Date:Sep 30, 1997TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Sep 30, 1997TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Sep 30, 1997TE:ABRLD:Yes

Expired US Patents for NDA 020757

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-003 Sep 30, 1997   Start Trial   Start Trial
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-001 Sep 30, 1997   Start Trial   Start Trial
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-002 Sep 30, 1997   Start Trial   Start Trial
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-002 Sep 30, 1997   Start Trial   Start Trial
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-003 Sep 30, 1997   Start Trial   Start Trial
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-001 Sep 30, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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