Last Updated: June 25, 2026

Details for New Drug Application (NDA): 211107

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NDA 211107 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 211107

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

Pharmacology for NDA: 211107

Mechanism of Action	Endothelin Receptor Antagonists

Suppliers and Packaging for NDA: 211107

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MACITENTAN	macitentan	TABLET;ORAL	211107	ANDA	Torrent Pharmaceuticals Limited	13668-542	13668-542-05	500 TABLET in 1 BOTTLE (13668-542-05)
MACITENTAN	macitentan	TABLET;ORAL	211107	ANDA	Torrent Pharmaceuticals Limited	13668-542	13668-542-30	30 TABLET in 1 BOTTLE (13668-542-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Aug 5, 2024	TE:	AB	RLD:	No

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