Last Updated: June 9, 2026

Details for New Drug Application (NDA): 207843

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NDA 207843 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, 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. Eight suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.

Summary for 207843

Tradename:	TELMISARTAN
Applicant:	Hisun Pharm Hangzhou
Ingredient:	telmisartan
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Feb 19, 2019	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Feb 19, 2019	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	80MG
Approval Date:	Feb 19, 2019	TE:		RLD:	No

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