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 two 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-two 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

Pharmacology for NDA: 020757

Mechanism of Action	Angiotensin 2 Receptor Antagonists

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)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	75MG
Approval Date:	Sep 30, 1997	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Sep 30, 1997	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Sep 30, 1997	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020757

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

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