← FDA Drug Approvals (Drugs@FDA)

HARLIKU

NDA · New Drug Application · Sponsor: CYCLE · Approved 2017-07-26

Drug application

FDA Application #

NDA209449

Application type

New Drug Application

Brand name

HARLIKU

Generic name

NITISINONE

Active ingredients

NITISINONE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

CYCLE

Manufacturer

Cycle Pharmaceuticals Ltd.

First approval

2017-07-26

Source

Authoritative

Drugs@FDA application overview

Machine

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