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Generic Name: irbesartan

Summary for Generic Name: irbesartan

Drug Master File Entries: see list37
Suppliers: see list7
Therapeutic Class:Cardiovascular Agents

Pharmacology for Ingredient: irbesartan

Tentative approvals for IRBESARTAN

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL300MG; 25MG
<disabled><disabled>TABLET; ORAL150MG; 12.5MG
<disabled><disabled>TABLET; ORAL300MG; 12.5MG

Clinical Trials for: irbesartan

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Status: Withdrawn Condition: Obesity; Hypertension

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

Courtesy of ClinicalTrials.org
See more clinical trials for this drug

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Zydus Pharms Usa Inc
TABLET;ORAL079213Sep 27, 2012RXNo<disabled>
Watson Labs Inc
TABLET;ORAL090720Oct 12, 2012RXNo<disabled>
Teva Pharms
TABLET;ORAL077159Mar 30, 2012RXNo<disabled>
TABLET;ORAL077466Sep 27, 2012RXNo<disabled>
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