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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 203171

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NDA 203171 describes TELMISARTAN, which is a drug marketed by Alembic, Amneal Pharms, Aurobindo Pharma, Cadila Pharms Ltd, Chartwell Rx, Glenmark Pharms Ltd, Hetero Labs Ltd V, Hisun Pharm Hangzhou, Inventia, Jubilant Generics, Macleods Pharms Ltd, Mankind Pharma, Micro Labs, Mylan, Prinston Inc, Sandoz, Torrent, Zydus Pharms, Lupin Ltd, and Natco, and is included in thirty-two NDAs. It is available from twenty-eight suppliers. Additional details are available on the TELMISARTAN profile page.

The generic ingredient in TELMISARTAN 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 203171

Tradename:	TELMISARTAN
Applicant:	Torrent
Ingredient:	telmisartan
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Jul 7, 2014	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Jul 7, 2014	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	80MG
Approval Date:	Jul 7, 2014	TE:	AB	RLD:	No

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