APPLICATION
ANDA074495
TYPE
ANDA
ORIGINAL APPROVAL
1994-12-05
LATEST ACTION
2025-08-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NAPROXEN SODIUMDiscontinued
NAPROXEN SODIUM EQ 500MG BASE · TABLET · ORAL
NAPROXEN SODIUMDiscontinued
NAPROXEN SODIUM EQ 250MG BASE · TABLET · ORAL
Approval history
2025-08-28Labeling · Supplement 15 · standardAP
2025-08-28Labeling · Supplement 13 · standardAP
2025-08-28Labeling · Supplement 11 · standardAP
2000-12-04Manufacturing (CMC) · Supplement 9AP
2000-12-04Manufacturing (CMC) · Supplement 8AP
2000-03-27Manufacturing (CMC) · Supplement 7AP
2000-03-27Manufacturing (CMC) · Supplement 5AP
2000-03-27Manufacturing (CMC) · Supplement 6AP
1996-06-24Manufacturing (CMC) · Supplement 3AP
1996-04-29Manufacturing (CMC) · Supplement 4AP
1996-01-19Labeling · Supplement 2AP
1994-12-05OriginalAP
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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