APPLICATION
ANDA090872
TYPE
ANDA
ORIGINAL APPROVAL
2018-09-04
LATEST ACTION
2024-02-13
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
2024-02-13Labeling · Supplement 2 · standardAP
2020-03-25Labeling · Supplement 1 · standardAP
2018-09-04OriginalAP
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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