APPLICATION
ANDA077744
TYPE
ANDA
ORIGINAL APPROVAL
2009-08-10
LATEST ACTION
2023-03-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SUMATRIPTAN SUCCINATEPrescription
SUMATRIPTAN SUCCINATE EQ 100MG BASE · TABLET · ORAL
SUMATRIPTAN SUCCINATEPrescription
SUMATRIPTAN SUCCINATE EQ 25MG BASE · TABLET · ORAL
SUMATRIPTAN SUCCINATEPrescription
SUMATRIPTAN SUCCINATE EQ 50MG BASE · TABLET · ORAL
Approval history
2023-03-31Labeling · Supplement 13 · standardAP
2021-07-01Manufacturing (CMC) · Supplement 11 · unknownAP
2019-04-16Labeling · Supplement 8 · standardAP
2015-06-19Labeling · Supplement 4 · standardAP
2015-06-19Labeling · Supplement 5 · standardAP
2012-01-11Labeling · Supplement 2AP
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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