Last Updated: June 25, 2026

Details for New Drug Application (NDA): 211120

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NDA 211120 describes MACITENTAN, which is a drug marketed by Alembic, Apotex, Aurobindo Pharma Ltd, Laurus, MSN, Mylan, Seasons Biotech, Sun Pharm, Torrent, and Zydus Lifesciences, and is included in ten NDAs. It is available from eleven suppliers. Additional details are available on the MACITENTAN profile page.

The generic ingredient in MACITENTAN is macitentan. There are ten drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the macitentan profile page.

Summary for 211120

Tradename:	MACITENTAN
Applicant:	Laurus
Ingredient:	macitentan
Patents:	0

Pharmacology for NDA: 211120

Mechanism of Action	Endothelin Receptor Antagonists

Suppliers and Packaging for NDA: 211120

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MACITENTAN	macitentan	TABLET;ORAL	211120	ANDA	Laurus Labs Limited	42385-907	42385-907-15	1 BLISTER PACK in 1 CARTON (42385-907-15) / 15 TABLET, FILM COATED in 1 BLISTER PACK
MACITENTAN	macitentan	TABLET;ORAL	211120	ANDA	Laurus Labs Limited	42385-907	42385-907-30	30 TABLET, FILM COATED in 1 BOTTLE (42385-907-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Nov 5, 2025	TE:	AB	RLD:	No

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