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Last Updated: April 17, 2026

Details for New Drug Application (NDA): 210715

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NDA 210715 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 210715

Tradename:	AMBRISENTAN
Applicant:	Cipla
Ingredient:	ambrisentan
Patents:	0

Pharmacology for NDA: 210715

Mechanism of Action	Endothelin Receptor Antagonists

Suppliers and Packaging for NDA: 210715

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMBRISENTAN	ambrisentan	TABLET;ORAL	210715	ANDA	Cipla USA Inc.	69097-386	69097-386-02	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69097-386-02)
AMBRISENTAN	ambrisentan	TABLET;ORAL	210715	ANDA	Cipla USA Inc.	69097-386	69097-386-19	1 BLISTER PACK in 1 CARTON (69097-386-19) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Apr 26, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Apr 26, 2019	TE:	AB	RLD:	No

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