Last Updated: July 28, 2026

Details for New Drug Application (NDA): 211187

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NDA 211187 describes MACITENTAN, which is a drug marketed by Alembic, Amneal, Apotex, Aurobindo Pharma Ltd, Laurus, MSN, Mylan, Seasons Biotech, Sun Pharm, Teva Pharms Usa Inc, Torrent, and Zydus Lifesciences, and is included in twelve NDAs. It is available from thirteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the macitentan profile page.

Summary for 211187

Tradename:	MACITENTAN
Applicant:	Teva Pharms Usa Inc
Ingredient:	macitentan
Patents:	0

Pharmacology for NDA: 211187

Mechanism of Action	Endothelin Receptor Antagonists

Suppliers and Packaging for NDA: 211187

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MACITENTAN	macitentan	TABLET;ORAL	211187	ANDA	Teva Pharmaceuticals, Inc.	0480-0915	0480-0915-56	30 TABLET, FILM COATED in 1 BOTTLE (0480-0915-56)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Jun 8, 2026	TE:	AB	RLD:	No

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