Last Updated: November 15, 2026

Details for New Drug Application (NDA): 207110

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NDA 207110 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 207110

Tradename:	BOSENTAN
Applicant:	Watson Labs Inc
Ingredient:	bosentan
Patents:	0

Pharmacology for NDA: 207110

Mechanism of Action	Cytochrome P450 2C9 Inducers Cytochrome P450 3A Inducers Endothelin Receptor Antagonists

Suppliers and Packaging for NDA: 207110

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BOSENTAN	bosentan	TABLET;ORAL	207110	ANDA	Actavis Pharma, Inc.	0591-2511	0591-2511-60	60 TABLET, FILM COATED in 1 BOTTLE (0591-2511-60)
BOSENTAN	bosentan	TABLET;ORAL	207110	ANDA	Actavis Pharma, Inc.	0591-2512	0591-2512-60	60 TABLET, FILM COATED in 1 BOTTLE (0591-2512-60)

Profile for product number 001

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

Profile for product number 002

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

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