APPLICATION
ANDA200629
TYPE
ANDA
ORIGINAL APPROVAL
2011-10-31
LATEST ACTION
2025-07-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NAPROXEN SODIUMPrescription
NAPROXEN SODIUM EQ 500MG BASE · TABLET · ORAL
NAPROXEN SODIUMPrescription
NAPROXEN SODIUM EQ 250MG BASE · TABLET · ORAL
Approval history
2025-07-24Labeling · Supplement 18 · standardAP
2019-12-06Labeling · Supplement 7 · standardAP
2019-12-06Labeling · Supplement 10 · standardAP
2019-12-06Labeling · Supplement 6 · standardAP
2015-04-02Labeling · Supplement 3 · standardAP
2011-10-31Not Applicable · 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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