APPLICATION
ANDA204048
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-30
LATEST ACTION
2021-08-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
RILUZOLEPrescription
RILUZOLE 50MG · TABLET · ORAL
Approval history
2021-08-13Labeling · Supplement 1 · standardAP
2021-08-13Labeling · Supplement 2 · standardAP
2016-03-30UNKNOWN · 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.
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