Details for New Drug Application (NDA): 210784

NDA 210784 describes AMBRISENTAN, which is a drug marketed by Apotex, Aurobindo Pharma, Cipla, Endo Operations, Mylan, Sigmapharm Labs Llc, Sun Pharm, Watson Labs Inc, and Zydus Pharms, and is included in nine NDAs. It is available from ten 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. Eleven suppliers are listed for this compound. Additional details are available on the ambrisentan profile page.

Summary for 210784

Tradename:	AMBRISENTAN
Applicant:	Sun Pharm
Ingredient:	ambrisentan
Patents:	0

Pharmacology for NDA: 210784

Mechanism of Action

Endothelin Receptor Antagonists

Suppliers and Packaging for NDA: 210784

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMBRISENTAN	ambrisentan	TABLET;ORAL	210784	ANDA	Sun Pharmaceutical Industries, Inc.	47335-236	47335-236-64	3 BLISTER PACK in 1 CARTON (47335-236-64) / 10 TABLET, FILM COATED in 1 BLISTER PACK (47335-236-60)
AMBRISENTAN	ambrisentan	TABLET;ORAL	210784	ANDA	Sun Pharmaceutical Industries, Inc.	47335-236	47335-236-66	1 BLISTER PACK in 1 CARTON (47335-236-66) / 10 TABLET, FILM COATED in 1 BLISTER PACK (47335-236-60)

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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