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ROZEREM

NDA · New Drug Application · Sponsor: TAKEDA PHARMS USA · Approved 2005-07-22

Drug application

FDA Application #

NDA021782

Application type

New Drug Application

Brand name

ROZEREM

Generic name

RAMELTEON

Active ingredients

RAMELTEON

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

TAKEDA PHARMS USA

Manufacturer

Takeda Pharmaceuticals America, Inc.

First approval

2005-07-22

Source

Authoritative

Drugs@FDA application overview

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