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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 three suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the AVALIDE profile page.

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

Summary for NDA: 020758

Tradename:
AVALIDE
Applicant:
Sanofi Aventis Us
Ingredient:
hydrochlorothiazide; irbesartan
Patents:1
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 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 0024-5855 0024-5855-90 90 TABLET, FILM COATED in 1 BOTTLE (0024-5855-90)

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No
Patent:5,994,348*PEDPatent Expiration:Dec 7, 2015Product Flag?Substance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;150MG
Approval Date:Sep 30, 1997TE:ABRLD:Yes
Patent:5,994,348*PEDPatent Expiration:Dec 7, 2015Product Flag?Substance Flag?Delist Request?

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;300MG
Approval Date:Aug 31, 1998TE:ABRLD:Yes
Patent:5,994,348*PEDPatent Expiration:Dec 7, 2015Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 020758

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
AVALIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL020758-001Sep 30, 19975,270,317*PED► subscribe
Sanofi Aventis Us
AVALIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL020758-003Aug 31, 19985,270,317*PED► subscribe
Sanofi Aventis Us
AVALIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL020758-004Mar 15, 20055,270,317*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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