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Last Updated: December 12, 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, 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 213154

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

Pharmacology for NDA: 213154

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

Suppliers and Packaging for NDA: 213154

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BOSENTAN	bosentan	TABLET, FOR SUSPENSION;ORAL	213154	ANDA	Lupin Pharmaceuticals, Inc.	68180-340	68180-340-13	4 BLISTER PACK in 1 CARTON (68180-340-13) / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK

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
Regulatory Exclusivity Expiration:	Feb 14, 2026
Regulatory Exclusivity Use:	PATENT CHALLENGE

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