← FDA Drug Approvals (Drugs@FDA)

HETLIOZ

NDA · New Drug Application · Sponsor: VANDA PHARMS INC · Approved 2014-01-31

Drug application

FDA Application #

NDA205677

Application type

New Drug Application

Brand name

HETLIOZ

Generic name

TASIMELTEON

Active ingredients

TASIMELTEON

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

VANDA PHARMS INC

Manufacturer

Vanda Pharmaceuticals Inc.

First approval

2014-01-31

Source

Authoritative

Drugs@FDA application overview

Machine

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