Last Updated: June 25, 2026

Details for New Drug Application (NDA): 211128

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NDA 211128 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 211128

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

Pharmacology for NDA: 211128

Mechanism of Action	Endothelin Receptor Antagonists

Suppliers and Packaging for NDA: 211128

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MACITENTAN	macitentan	TABLET;ORAL	211128	ANDA	Alembic Pharmaceuticals Limited	46708-373	46708-373-30	30 TABLET, FILM COATED in 1 BOTTLE (46708-373-30)
MACITENTAN	macitentan	TABLET;ORAL	211128	ANDA	Alembic Pharmaceuticals Inc.	62332-373	62332-373-30	30 TABLET, FILM COATED in 1 BOTTLE (62332-373-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Aug 18, 2025	TE:	AB	RLD:	No

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