🇺🇸 FDA

Drug profile · INN

bosentan

TRACLEER

approved C02KX01
US status
approved
Patents linked
0
News articles
0

Quick answer

bosentan (TRACLEER) is an FDA-listed pharmaceutical active ingredient. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN bosentan
Brand TRACLEER
Route ORAL
Formulation TABLET, FOR SUSPENSION
ATC code C02KX01

Frequently asked questions

What is bosentan?

bosentan (TRACLEER) is an FDA-listed pharmaceutical active ingredient. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for bosentan?

TRACLEER is a marketed brand name for bosentan. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of bosentan?

bosentan has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.