Details for New Drug Application (NDA): 211123

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NDA 211123 describes MACITENTAN, which is a drug marketed by Alembic, Apotex, Aurobindo Pharma Ltd, Laurus, MSN, Sun Pharm, Torrent, and Zydus Lifesciences, and is included in eight NDAs. 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. One supplier is listed for this compound. Additional details are available on the macitentan profile page.

Summary for 211123

Tradename:	MACITENTAN
Applicant:	Sun Pharm
Ingredient:	macitentan
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Aug 26, 2025	TE:	AB	RLD:	No

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