APPLICATION
ANDA202803
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-20
LATEST ACTION
2025-11-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SUMATRIPTAN AND NAPROXEN SODIUMPrescription
NAPROXEN SODIUM 500MG, SUMATRIPTAN SUCCINATE EQ 85MG BASE · TABLET · ORAL
Approval history
2025-11-10Labeling · Supplement 6 · standardAP
2025-11-10Labeling · Supplement 13 · standardAP
2025-11-10Labeling · Supplement 9 · standardAP
2020-12-04Labeling · Supplement 1 · standardAP
2018-07-20UNKNOWN · OriginalAP
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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