APPLICATION
ANDA208004
TYPE
ANDA
ORIGINAL APPROVAL
2020-12-30
LATEST ACTION
2025-02-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
FINGOLIMOD HYDROCHLORIDEPrescription
FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE · CAPSULE · ORAL
Approval history
2025-02-19Labeling · Supplement 7 · standardAP
2024-05-30Labeling · Supplement 4 · standardAP
2020-12-30UNKNOWN · 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.
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