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Generated: December 10, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091539

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NDA 091539 describes IRBESARTAN AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic Pharms Ltd, Apotex Inc, Atlas Pharms Llc, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hisun Pharm Hangzhou, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Sandoz, Teva, Unichem Labs Ltd, Watson Labs Inc, and West-ward Pharms Int, and is included in fifteen NDAs. It is available from sixteen suppliers. Additional details are available on the IRBESARTAN AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in IRBESARTAN AND HYDROCHLOROTHIAZIDE 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 091539

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength12.5MG;150MG
Approval Date:Oct 22, 2012TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength12.5MG;300MG
Approval Date:Oct 22, 2012TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Cipla
McKesson
UBS
US Army
Chubb
Medtronic
Express Scripts
Johnson and Johnson
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US Department of Justice

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