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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 210784


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NDA 210784 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 210784
Tradename:AMBRISENTAN
Applicant:Sun Pharm
Ingredient:ambrisentan
Patents:0
Pharmacology for NDA: 210784
Mechanism of ActionEndothelin 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:RXDosage:TABLET;ORALStrength5MG
Approval Date:Mar 28, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Mar 28, 2019TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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