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TRACLEER

NDA · New Drug Application · Sponsor: ACTELION · Approved 2017-09-05

Drug application

FDA Application #

NDA209279

Application type

New Drug Application

Brand name

TRACLEER

Generic name

BOSENTAN

Active ingredients

BOSENTAN

Dosage form

TABLET, FOR SUSPENSION

Route

ORAL

Marketing status

Prescription

Sponsor

ACTELION

Manufacturer

Actelion Pharmaceuticals US, Inc.

First approval

2017-09-05

Source

Authoritative

Drugs@FDA application overview

Machine

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