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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 211461

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NDA 211461 describes BOSENTAN, which is a drug marketed by Alembic, Alvogen Pine Brook, Amneal Pharms Co, Chartwell Molecular, Endo Operations, Hikma, Mylan, Natco Pharma Ltd, Sun Pharm, Watson Labs Inc, and Zydus Pharms, and is included in eleven 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 211461

Tradename:	BOSENTAN
Applicant:	Alembic
Ingredient:	bosentan
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	62.5MG
Approval Date:	Jan 23, 2020	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	125MG
Approval Date:	Jan 23, 2020	TE:		RLD:	No

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