APPLICATION
ANDA207979
TYPE
ANDA
ORIGINAL APPROVAL
2019-12-04
LATEST ACTION
2026-03-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
FINGOLIMOD HYDROCHLORIDEPrescription
FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE · CAPSULE · ORAL
Approval history
2026-03-12Labeling · Supplement 11 · standardAP
2026-03-12Labeling · Supplement 8 · standardAP
2024-04-16Labeling · Supplement 6 · standardAP
2021-02-09Labeling · Supplement 2 · standardAP
2019-12-04UNKNOWN · 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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