APPLICATION
ANDA219036
TYPE
ANDA
ORIGINAL APPROVAL
2024-12-31
LATEST ACTION
2025-03-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SUMATRIPTAN SUCCINATEPrescription
SUMATRIPTAN SUCCINATE EQ 25MG BASE · TABLET · ORAL
SUMATRIPTAN SUCCINATEPrescription
SUMATRIPTAN SUCCINATE EQ 50MG BASE · TABLET · ORAL
SUMATRIPTAN SUCCINATEPrescription
SUMATRIPTAN SUCCINATE EQ 100MG BASE · TABLET · ORAL
Approval history
2025-03-28Manufacturing (CMC) · Supplement 2 · unknownAP
2025-03-17Manufacturing (CMC) · Supplement 1 · unknownAP
2024-12-31UNKNOWN · 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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