APPLICATION
ANDA078432
TYPE
ANDA
ORIGINAL APPROVAL
2007-04-25
LATEST ACTION
2025-06-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NAPROXEN SODIUMDiscontinued
NAPROXEN SODIUM EQ 250MG BASE · TABLET · ORAL
NAPROXEN SODIUMDiscontinued
NAPROXEN SODIUM EQ 500MG BASE · TABLET · ORAL
Approval history
2025-06-02Labeling · Supplement 17 · standardAP
2025-06-02Labeling · Supplement 13 · standardAP
2025-06-02Labeling · Supplement 11 · standardAP
2025-06-02Labeling · Supplement 18 · standardAP
2019-12-03Labeling · Supplement 6 · standardAP
2019-12-03Labeling · Supplement 4 · standardAP
2019-12-03Labeling · Supplement 9 · standardAP
2015-05-04Labeling · Supplement 3 · standardAP
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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