Last Updated: September 24, 2026

Details for New Drug Application (NDA): 210342

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NDA 210342 describes BOSENTAN, which is a drug marketed by Natco Pharma Ltd, Zydus Pharms, Alembic, Alvogen Pine Brook, Amneal Pharms Co, Chartwell Molecular, Hikma, Mylan, Ph Health, Sun Pharm, and Watson Labs Inc, and is included in thirteen NDAs. It is available from five suppliers. Additional details are available on the BOSENTAN profile page.

The generic ingredient in BOSENTAN is bosentan. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the bosentan profile page.

Summary for 210342

Tradename:	BOSENTAN
Applicant:	Chartwell Molecular
Ingredient:	bosentan
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	62.5MG
Approval Date:	Jan 3, 2020	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	125MG
Approval Date:	Jan 3, 2020	TE:		RLD:	No

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