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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 201524

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NDA 201524 describes IRBESARTAN AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic, Apotex Inc, Atlas Pharms Llc, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hikma, Hisun Pharm Hangzhou, Lupin Ltd, Macleods Pharms Ltd, Pharmobedient, Prinston Inc, Sandoz, Teva, Unichem, and Watson Labs Inc, and is included in fifteen NDAs. It is available from twelve 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-two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.

Summary for 201524

Tradename:	IRBESARTAN AND HYDROCHLOROTHIAZIDE
Applicant:	Lupin Ltd
Ingredient:	hydrochlorothiazide; irbesartan
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG;150MG
Approval Date:	Feb 27, 2013	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG;300MG
Approval Date:	Feb 27, 2013	TE:	AB	RLD:	No

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