You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 26, 2026

Details for New Drug Application (NDA): 216531

✉ Email this page to a colleague

« Back to Dashboard

NDA 216531 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 216531

Tradename:	AMBRISENTAN
Applicant:	Aurobindo Pharma
Ingredient:	ambrisentan
Patents:	0

Pharmacology for NDA: 216531

Mechanism of Action	Endothelin Receptor Antagonists

Suppliers and Packaging for NDA: 216531

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMBRISENTAN	ambrisentan	TABLET;ORAL	216531	ANDA	A-S Medication Solutions	50090-7670	50090-7670-0	30 TABLET, FILM COATED in 1 BOTTLE (50090-7670-0)
AMBRISENTAN	ambrisentan	TABLET;ORAL	216531	ANDA	A-S Medication Solutions	50090-7671	50090-7671-0	30 TABLET, FILM COATED in 1 BOTTLE (50090-7671-0)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Jul 21, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Jul 21, 2022	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.