APPLICATION
ANDA218459
TYPE
ANDA
ORIGINAL APPROVAL
2026-03-06
LATEST ACTION
2026-03-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SIPONIMODDiscontinued
SIPONIMOD EQ 2MG BASE · TABLET · ORAL
SIPONIMODDiscontinued
SIPONIMOD EQ 0.25MG BASE · TABLET · ORAL
SIPONIMODDiscontinued
SIPONIMOD EQ 1MG BASE · TABLET · ORAL
Approval history
2026-03-06UNKNOWN · 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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