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FDA NDA · NDA209080

TIGLUTIK

riluzole

Sponsor: ITALFARMACO SA

APPLICATION
NDA209080
TYPE
NDA
ORIGINAL APPROVAL
2018-09-05
LATEST ACTION
2025-09-11
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

TIGLUTIK KIT · ReferencePrescription
RILUZOLE 50MG/10ML · SUSPENSION · ORAL

Approval history

2025-09-11Labeling · Supplement 5 · standard — Letter ↗AP
2020-05-11Labeling · Supplement 3 · standard — Label ↗AP
2019-12-13Efficacy · Supplement 1 · standard — Label ↗AP
2018-09-05Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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