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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079213

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NDA 079213 describes IRBESARTAN, which is a drug marketed by Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Molecular, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hisun Pharm Hangzhou, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Sandoz, Sciegen Pharms Inc, Teva Pharms, Unichem Labs Ltd, Watson Labs Inc, West-ward Pharms Int, Zydus Pharms Usa Inc, Atlas Pharms Llc, and Teva, and is included in thirty-six NDAs. It is available from twenty-six suppliers. Additional details are available on the IRBESARTAN profile page.

The generic ingredient in IRBESARTAN 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 079213
Tradename:IRBESARTAN
Applicant:Zydus Pharms Usa Inc
Ingredient:irbesartan
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 079213
Suppliers and Packaging for NDA: 079213
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IRBESARTAN irbesartan TABLET;ORAL 079213 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-299 N 68382-299-05
IRBESARTAN irbesartan TABLET;ORAL 079213 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-299 N 68382-299-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength75MG
Approval Date:Sep 27, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Sep 27, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Sep 27, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Citi
Daiichi Sankyo
Moodys
Express Scripts
Boehringer Ingelheim
Cantor Fitzgerald
Accenture
Mallinckrodt

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