Details for New Drug Application (NDA): 020758

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NDA 020758 describes AVALIDE, 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 AVALIDE profile page.

The generic ingredient in AVALIDE is hydrochlorothiazide; irbesartan. There are thirty-two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.

Summary for 020758

Tradename:	AVALIDE
Applicant:	Sanofi Aventis Us
Ingredient:	hydrochlorothiazide; irbesartan
Patents:	0

Pharmacology for NDA: 020758

Mechanism of Action	Angiotensin 2 Receptor Antagonists
Physiological Effect	Increased Diuresis

Suppliers and Packaging for NDA: 020758

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758	NDA	Sanofi-Aventis U.S. LLC	0024-5855	0024-5855-30	30 TABLET, FILM COATED in 1 BOTTLE (0024-5855-30)
AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758	NDA	Sanofi-Aventis U.S. LLC	0024-5856	0024-5856-30	30 TABLET, FILM COATED in 1 BOTTLE (0024-5856-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	12.5MG;75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Sep 30, 1997	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG;150MG
Approval Date:	Sep 30, 1997	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG;300MG
Approval Date:	Aug 31, 1998	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020758

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-001	Sep 30, 1997	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-002	Sep 30, 1997	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-003	Aug 31, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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