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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Fish and Richardson
Colorcon
Express Scripts
Merck
Baxter
Covington
Mallinckrodt
Accenture

Generated: May 21, 2018

DrugPatentWatch Database Preview

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. Nineteen 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 020758
Ingredient-typeThiazides
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased 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 N 0024-5855-30
AVALIDE hydrochlorothiazide; irbesartan TABLET;ORAL 020758 NDA sanofi-aventis U.S. LLC 0024-5855 N 0024-5855-90

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Sep 30, 1997TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;150MG
Approval Date:Sep 30, 1997TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;300MG
Approval Date:Aug 31, 1998TE:ABRLD:Yes

Expired US Patents for NDA 020758

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us AVALIDE hydrochlorothiazide; irbesartan TABLET;ORAL 020758-004 Mar 15, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us AVALIDE hydrochlorothiazide; irbesartan TABLET;ORAL 020758-002 Sep 30, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us AVALIDE hydrochlorothiazide; irbesartan TABLET;ORAL 020758-001 Sep 30, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us AVALIDE hydrochlorothiazide; irbesartan TABLET;ORAL 020758-003 Aug 31, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Teva
Chinese Patent Office
UBS
Accenture
Mallinckrodt
Healthtrust
Fish and Richardson
McKinsey

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