← FDA DRUG APPROVALS

FDA NDA · NDA020599

RILUTEK

Sponsor: AZURITY

APPLICATION
NDA020599
TYPE
NDA
ORIGINAL APPROVAL
1995-12-12
LATEST ACTION
2025-09-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

RILUTEK · ReferenceDiscontinued
RILUZOLE 50MG · TABLET · ORAL

Approval history

2025-09-11Labeling · Supplement 21 · standard — Letter ↗AP
2020-05-11Labeling · Supplement 19 · standard — Label ↗AP
2016-04-08Labeling · Supplement 17 · standard — Letter ↗AP
2009-11-16Labeling · Supplement 13 · standard — Review ↗AP
2009-07-10Labeling · Supplement 11 · standard — Review ↗AP
2009-07-10Labeling · Supplement 12 · standard — Review ↗AP
2004-09-21Labeling · Supplement 8 · standard — Review ↗AP
2003-05-19Labeling · Supplement 2 · standard — Review ↗AP
2003-05-19Labeling · Supplement 5 · standard — Review ↗AP
2003-05-19Labeling · Supplement 3 · standard — Review ↗AP
2000-04-10Labeling · Supplement 6 · standardAP
1999-04-09Manufacturing (CMC) · Supplement 4 · priorityAP
1996-11-04Manufacturing (CMC) · Supplement 1 · priorityAP
1995-12-12Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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