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ORFADIN

NDA · New Drug Application · Sponsor: SWEDISH ORPHAN · Approved 2016-04-22

Drug application

FDA Application #

NDA206356

Application type

New Drug Application

Brand name

ORFADIN

Generic name

NITISINONE

Active ingredients

NITISINONE

Dosage form

SUSPENSION

Route

ORAL

Marketing status

Prescription

Sponsor

SWEDISH ORPHAN

Manufacturer

Swedish Orphan Biovitrum AB (publ)

First approval

2016-04-22

Source

Authoritative

Drugs@FDA application overview

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