APPLICATION
ANDA207983
TYPE
ANDA
ORIGINAL APPROVAL
2024-02-28
LATEST ACTION
2026-02-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
FINGOLIMOD HYDROCHLORIDEPrescription
FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE · CAPSULE · ORAL
Approval history
2026-02-24Labeling · Supplement 2 · standardAP
2025-01-22Labeling · Supplement 1 · 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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