Details for New Drug Application (NDA): 211198

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NDA 211198 describes MACITENTAN, which is a drug marketed by Apotex, Aurobindo Pharma Ltd, Torrent, and Zydus Lifesciences, and is included in four 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 211198

Tradename:	MACITENTAN
Applicant:	Aurobindo Pharma Ltd
Ingredient:	macitentan
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Apr 18, 2023	TE:		RLD:	No

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