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OPSYNVI

NDA · New Drug Application · Sponsor: ACTELION · Approved 2024-03-22

Drug application

FDA Application #

NDA218490

Application type

New Drug Application

Brand name

OPSYNVI

Generic name

MACITENTAN AND TADALAFIL

Active ingredients

MACITENTAN; TADALAFIL

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ACTELION

Manufacturer

Actelion Pharmaceuticals US, Inc.

First approval

2024-03-22

Source

Authoritative

Drugs@FDA application overview

Machine

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