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Generated: August 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203161

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NDA 203161 describes IRBESARTAN, which is a drug marketed by West-ward Pharms Int, Cipla Ltd, Hetero Labs Ltd V, Zydus Pharms Usa Inc, Unichem Labs Ltd, Watson Labs Inc, Lupin Ltd, Apotex Inc, Jubilant Generics, Alembic Pharms Ltd, Macleods Pharms Ltd, Teva Pharms, Dr Reddys Labs Ltd, Mylan Pharms Inc, Sandoz, Prinston Inc, Sciegen Pharms Inc, Aurobindo Pharma Ltd, Ajanta Pharma Ltd, Hisun Pharm Hangzhou, Atlas Pharms Llc, and Teva, and is included in thirty-four NDAs. It is available from twenty-one suppliers. Additional details are available on the IRBESARTAN profile page.

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

Summary for NDA: 203161

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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