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DULERA

NDA · New Drug Application · Sponsor: ORGANON LLC · Approved 2010-06-22

Drug application

FDA Application #

NDA022518

Application type

New Drug Application

Brand name

DULERA

Generic name

MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE

Active ingredients

FORMOTEROL FUMARATE; MOMETASONE FUROATE

Dosage form

AEROSOL, METERED

Route

INHALATION

Marketing status

Prescription

Sponsor

ORGANON LLC

Manufacturer

Organon LLC

First approval

2010-06-22

Source

Authoritative

Drugs@FDA application overview

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