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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 204221

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NDA 204221 describes TELMISARTAN AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic, Aurobindo Pharma, Glenmark Pharms Ltd, Lupin Ltd, Macleods Pharms Ltd, Mankind Pharma, Natco, Prinston Inc, Torrent, and Zydus Pharms, and is included in ten NDAs. It is available from six suppliers. Additional details are available on the TELMISARTAN AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in TELMISARTAN AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; telmisartan. There are thirty-two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.

Summary for 204221

Tradename:	TELMISARTAN AND HYDROCHLOROTHIAZIDE
Applicant:	Zydus Pharms
Ingredient:	hydrochlorothiazide; telmisartan
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG;40MG
Approval Date:	Aug 15, 2017	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG;80MG
Approval Date:	Aug 15, 2017	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG;80MG
Approval Date:	Aug 15, 2017	TE:	AB	RLD:	No

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