Last Updated: November 9, 2026

Details for New Drug Application (NDA): 210058

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NDA 210058 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 is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the ambrisentan profile page.

Summary for 210058

Tradename:	AMBRISENTAN
Applicant:	Zydus Pharms
Ingredient:	ambrisentan
Patents:	0

Pharmacology for NDA: 210058

Mechanism of Action	Endothelin Receptor Antagonists

Suppliers and Packaging for NDA: 210058

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMBRISENTAN	ambrisentan	TABLET;ORAL	210058	ANDA	Zydus Pharmaceuticals USA Inc.	70710-1179	70710-1179-1	100 TABLET, FILM COATED in 1 BOTTLE (70710-1179-1)
AMBRISENTAN	ambrisentan	TABLET;ORAL	210058	ANDA	Zydus Pharmaceuticals USA Inc.	70710-1179	70710-1179-3	30 TABLET, FILM COATED in 1 BOTTLE (70710-1179-3)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Mar 28, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Mar 28, 2019	TE:	AB	RLD:	No

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