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BELSOMRA

NDA · New Drug Application · Sponsor: MERCK SHARP DOHME · Approved 2014-08-13

Drug application

FDA Application #

NDA204569

Application type

New Drug Application

Brand name

BELSOMRA

Generic name

SUVOREXANT

Active ingredients

SUVOREXANT

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

MERCK SHARP DOHME

Manufacturer

Merck Sharp & Dohme LLC

First approval

2014-08-13

Source

Authoritative

Drugs@FDA application overview

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