APPLICATION
ANDA078327
TYPE
ANDA
ORIGINAL APPROVAL
2009-08-10
LATEST ACTION
2022-06-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SUMATRIPTAN SUCCINATEPrescription
SUMATRIPTAN SUCCINATE EQ 50MG BASE · TABLET · ORAL
SUMATRIPTAN SUCCINATEPrescription
SUMATRIPTAN SUCCINATE EQ 100MG BASE · TABLET · ORAL
SUMATRIPTAN SUCCINATEPrescription
SUMATRIPTAN SUCCINATE EQ 25MG BASE · TABLET · ORAL
Approval history
2022-06-22Manufacturing (CMC) · Supplement 17 · unknownAP
2022-06-17Labeling · Supplement 16 · standardAP
2019-05-17Labeling · Supplement 11 · standardAP
2015-08-13Labeling · Supplement 6 · standardAP
2015-08-13Labeling · Supplement 3 · standardAP
2011-05-12Labeling · Supplement 1AP
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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