Last Updated: June 25, 2026

Details for New Drug Application (NDA): 211026

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NDA 211026 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 211026

Tradename:	MACITENTAN
Applicant:	Seasons Biotech
Ingredient:	macitentan
Patents:	0

Pharmacology for NDA: 211026

Mechanism of Action	Endothelin Receptor Antagonists

Suppliers and Packaging for NDA: 211026

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MACITENTAN	macitentan	TABLET;ORAL	211026	ANDA	Novugen Pharma (USA) LLC	82293-041	82293-041-10	1 BLISTER PACK in 1 CARTON (82293-041-10) / 15 TABLET, FILM COATED in 1 BLISTER PACK
MACITENTAN	macitentan	TABLET;ORAL	211026	ANDA	Novugen Pharma (USA) LLC	82293-041	82293-041-20	30 TABLET, FILM COATED in 1 BOTTLE (82293-041-20)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Dec 3, 2025	TE:	AB	RLD:	No

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