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Details for New Drug Application (NDA): 203500

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NDA 203500 describes IRBESARTAN AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Dr Reddys Labs Ltd, Apotex Inc, Macleods Pharms Ltd, Lupin Ltd, Aurobindo Pharma Ltd, Intl Speclt Chems, Watson Labs Inc, Sandoz, Roxane, Mylan Pharms Inc, Teva, Alembic Pharms Ltd, Prinston Inc, and Hisun Pharm Hangzhou, and is included in fourteen 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. There are four tentative approvals for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.

Summary for NDA: 203500

Tradename:
IRBESARTAN AND HYDROCHLOROTHIAZIDE
Applicant:
Dr Reddys Labs Ltd
Ingredient:
hydrochlorothiazide; irbesartan
Patents:0
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;150MG
Approval Date:Sep 27, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;300MG
Approval Date:Sep 27, 2012TE:ABRLD:No


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