APPLICATION
ANDA206045
TYPE
ANDA
ORIGINAL APPROVAL
2019-12-09
LATEST ACTION
2023-10-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
RILUZOLEPrescription
RILUZOLE 50MG · TABLET · ORAL
Approval history
2023-10-17Manufacturing (CMC) · Supplement 3 · unknownAP
2019-12-09UNKNOWN · Original · standardAP
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.