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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 210701


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NDA 210701 describes AMBRISENTAN, which is a drug marketed by Apotex, Aurobindo Pharma, Cipla, Mylan, Par Pharm Inc, Sigmapharm Labs Llc, Sun Pharm, Watson Labs Inc, and Zydus Pharms, and is included in nine NDAs. It is available from nine 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. Ten suppliers are listed for this compound. Additional details are available on the ambrisentan profile page.
Summary for 210701
Tradename:AMBRISENTAN
Applicant:Apotex
Ingredient:ambrisentan
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 210701
Mechanism of ActionEndothelin Receptor Antagonists
Suppliers and Packaging for NDA: 210701
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMBRISENTAN ambrisentan TABLET;ORAL 210701 ANDA Apotex Corp. 60505-4552 60505-4552-3 30 TABLET, FILM COATED in 1 BOTTLE (60505-4552-3)
AMBRISENTAN ambrisentan TABLET;ORAL 210701 ANDA Apotex Corp. 60505-4553 60505-4553-3 30 TABLET, FILM COATED in 1 BOTTLE (60505-4553-3)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 19, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 19, 2022TE:ABRLD:No

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