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Last Updated: March 25, 2025

Details for New Drug Application (NDA): 213154

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NDA 213154 describes BOSENTAN, which is a drug marketed by Natco Pharma Ltd, Alembic, Alvogen Pine Brook, Amneal Pharms Co, Chartwell Molecular, Endo Operations, Hikma, Mylan, 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 213154

Tradename:	BOSENTAN
Applicant:	Natco Pharma Ltd
Ingredient:	bosentan
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, FOR SUSPENSION;ORAL			Strength	32MG
Approval Date:	Feb 5, 2025	TE:	AB	RLD:	No

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