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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Argus Health
Daiichi Sankyo
Accenture
Federal Trade Commission
Teva
Mallinckrodt
Citi
Fish and Richardson

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200832

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NDA 200832 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 200832
Tradename:IRBESARTAN
Applicant:Apotex Inc
Ingredient:irbesartan
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength75MG
Approval Date:Oct 15, 2012TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength150MG
Approval Date:Oct 15, 2012TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength300MG
Approval Date:Oct 15, 2012TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Chinese Patent Office
Daiichi Sankyo
Johnson and Johnson
Cantor Fitzgerald
Teva
Fish and Richardson
Harvard Business School
Farmers Insurance

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