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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 208441

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NDA 208441 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 208441

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

Pharmacology for NDA: 208441

Mechanism of Action	Endothelin Receptor Antagonists

Suppliers and Packaging for NDA: 208441

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMBRISENTAN	ambrisentan	TABLET;ORAL	208441	ANDA	Mylan Pharmaceuticals Inc.	0378-4270	0378-4270-93	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4270-93)
AMBRISENTAN	ambrisentan	TABLET;ORAL	208441	ANDA	Mylan Pharmaceuticals Inc.	0378-4271	0378-4271-93	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4271-93)

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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