APPLICATION
ANDA207971
TYPE
ANDA
ORIGINAL APPROVAL
2020-06-29
LATEST ACTION
2026-02-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
FINGOLIMOD HYDROCHLORIDEDiscontinued
FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE · CAPSULE · ORAL
Approval history
2026-02-18Labeling · Supplement 4 · standardAP
2026-02-18Labeling · Supplement 3 · standardAP
2020-06-29UNKNOWN · 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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