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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 209742

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NDA 209742 describes BOSENTAN, which is a drug marketed by Natco Pharma Ltd, Alembic, Alvogen Pine Brook, Amneal Pharms Co, Chartwell Molecular, Hikma, Mylan, Ph Health, Sun Pharm, Watson Labs Inc, and Zydus Pharms, and is included in twelve NDAs. It is available from five suppliers. Additional details are available on the BOSENTAN profile page.

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

Summary for 209742

Tradename:	BOSENTAN
Applicant:	Amneal Pharms Co
Ingredient:	bosentan
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	62.5MG
Approval Date:	Apr 26, 2019	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	125MG
Approval Date:	Apr 26, 2019	TE:		RLD:	No

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