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Profile for Tradename: AVAPRO

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Avapro is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from seven suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

The generic ingredient in AVAPRO is irbesartan. There are thirty-seven drug master file entries for this compound. Seven suppliers are listed for this compound. There are five tentative approvals for this compound. Additional details are available on the irbesartan profile page.

Summary for Tradename: AVAPRO

Patents:1
Applicants:1
NDAs:1
Suppliers: see list7

Pharmacology for Tradename: AVAPRO

Clinical Trials for: AVAPRO

A Bioequivalence Study Comparing Irbesartan/Atorvastatin Combination Tablet With Coadministration of Irbesartan and Atorvastatin
Status: Completed Condition: Healthy

Irbesartan and Adhesion Molecules in AF
Status: Recruiting Condition: Persistent Atrial Fibrillation

A Clinical Study to Evaluate Renal Hemodynamic Responses to Aliskiren in Patients With Type 2 Diabetes Mellitus
Status: Completed Condition: Type 2 Diabetes Mellitus

Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)
Status: Completed Condition: Atrial Fibrillation

Irbesartan Versus Amlodipine: The OBI Study
Status: Withdrawn Condition: Obesity; Hypertension

Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe Hypertension
Status: Completed Condition: Hypertension

Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy for Patients With Moderate Hypertension
Status: Completed Condition: Hypertension

Drug Interaction Between Irbesartan and Hydrochlorothiazide
Status: Completed Condition: Healthy

Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension
Status: Completed Condition: Hypertension

Efficacy and Safety of Irbesartan and Atorvastatin in Hypertension and Hyperlipidemia
Status: Completed Condition: Hypertension; Hyperlipidemia

Courtesy of ClinicalTrials.org
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Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
AVAPRO
irbesartan
TABLET;ORAL020757Sep 30, 1997RXNo6,342,247*PED<disabled>Y<disabled>
Sanofi Aventis Us
AVAPRO
irbesartan
TABLET;ORAL020757Sep 30, 1997RXYes6,342,247*PED<disabled>Y<disabled>
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Paragraph IV activity for: AVAPRO

Drugname Dosage Strength RLD Submissiondate
irbesartanTablets75 mg, 150 mg and 300 mgAvapro5/25/2004
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