← FDA Drug Approvals (Drugs@FDA)

TIGLUTIK KIT

NDA · New Drug Application · Sponsor: ITALFARMACO SA · Approved 2018-09-05

Drug application

FDA Application #

NDA209080

Application type

New Drug Application

Brand name

TIGLUTIK KIT

Generic name

RILUZOLE

Active ingredients

RILUZOLE

Dosage form

SUSPENSION

Route

ORAL

Marketing status

Prescription

Sponsor

ITALFARMACO SA

Manufacturer

EDW PHARMA, INC

First approval

2018-09-05

Source

Authoritative

Drugs@FDA application overview

Machine

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