APPLICATION
ANDA203042
TYPE
ANDA
ORIGINAL APPROVAL
2013-07-01
LATEST ACTION
2021-09-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
RILUZOLEDiscontinued
RILUZOLE 50MG · TABLET · ORAL
Approval history
2021-09-08Labeling · Supplement 3 · standardAP
2021-09-08Labeling · Supplement 1 · standardAP
2013-07-01UNKNOWN · OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.