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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 209509

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NDA 209509 describes AMBRISENTAN, which is a drug marketed by Apotex, Aurobindo Pharma, Cipla, Mylan, Ph Health, Sigmapharm Labs Llc, Sun Pharm, Watson Labs Inc, and Zydus Pharms, and is included in nine NDAs. It is available from twelve suppliers. Additional details are available on the AMBRISENTAN profile page.

The generic ingredient in AMBRISENTAN is ambrisentan. There are nine drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the ambrisentan profile page.

Summary for 209509

Tradename:	AMBRISENTAN
Applicant:	Ph Health
Ingredient:	ambrisentan
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Apr 10, 2019	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Apr 10, 2019	TE:		RLD:	No

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