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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Colorcon
Medtronic
AstraZeneca
Baxter
Cerilliant
Queensland Health
Merck
Federal Trade Commission

Generated: June 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077205

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NDA 077205 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 077205
Tradename:IRBESARTAN
Applicant:Chartwell Molecular
Ingredient:irbesartan
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength75MG
Approval Date:Nov 14, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Nov 14, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Nov 14, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Moodys
Medtronic
Teva
Fish and Richardson
Fuji
Chinese Patent Office
Farmers Insurance
Dow

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