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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 200461

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NDA 200461 describes IRBESARTAN, which is a drug marketed by Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Molecular, Chartwell Rx, Hetero Labs Ltd V, Hikma, Hisun Pharm Hangzhou, Ipca Labs Ltd, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, MSN, Prinston Inc, Sandoz, Sciegen Pharms Inc, Teva Pharms, Unichem, Watson Labs Inc, Yiling, Zydus Pharms Usa Inc, Alembic, Atlas Pharms Llc, Dr Reddys Labs Ltd, Pharmobedient, and Teva, and is included in thirty-eight NDAs. It is available from twenty-two 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. Thirteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.

Summary for 200461

Tradename:	IRBESARTAN
Applicant:	Yiling
Ingredient:	irbesartan
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	75MG
Approval Date:	Sep 27, 2012	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Sep 27, 2012	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Sep 27, 2012	TE:		RLD:	No

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