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GILENYA

NDA · New Drug Application · Sponsor: NOVARTIS · Approved 2010-09-21

Drug application

FDA Application #

NDA022527

Application type

New Drug Application

Brand name

GILENYA

Generic name

FINGOLIMOD HCL

Active ingredients

FINGOLIMOD HYDROCHLORIDE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

NOVARTIS

Manufacturer

Novartis Pharmaceuticals Corporation

First approval

2010-09-21

Source

Authoritative

Drugs@FDA application overview

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