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ORENITRAM

NDA · New Drug Application · Sponsor: UNITED THERAP · Approved 2013-12-20

Drug application

FDA Application #

NDA203496

Application type

New Drug Application

Brand name

ORENITRAM

Generic name

TREPROSTINIL

Active ingredients

TREPROSTINIL DIOLAMINE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

UNITED THERAP

Manufacturer

United Therapeutics Corporation

First approval

2013-12-20

Source

Authoritative

Drugs@FDA application overview

Machine

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