Last Updated: May 25, 2026

Details for New Drug Application (NDA): 211224

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NDA 211224 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 two 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. Three suppliers are listed for this compound. Additional details are available on the macitentan profile page.

Summary for 211224

Tradename:	MACITENTAN
Applicant:	Zydus Lifesciences
Ingredient:	macitentan
Patents:	0

Pharmacology for NDA: 211224

Mechanism of Action	Endothelin Receptor Antagonists

Suppliers and Packaging for NDA: 211224

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MACITENTAN	macitentan	TABLET;ORAL	211224	ANDA	Zydus Pharmaceuticals USA Inc.	70710-1166	70710-1166-3	30 TABLET, FILM COATED in 1 BOTTLE (70710-1166-3)
MACITENTAN	macitentan	TABLET;ORAL	211224	ANDA	Zydus Pharmaceuticals USA Inc.	70710-1166	70710-1166-5	5 BLISTER PACK in 1 CARTON (70710-1166-5) / 3 TABLET, FILM COATED in 1 BLISTER PACK (70710-1166-4)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Apr 6, 2021	TE:		RLD:	No

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