APPLICATION
ANDA074142
TYPE
ANDA
ORIGINAL APPROVAL
1993-12-21
LATEST ACTION
2026-01-24
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
2026-01-24Labeling · Supplement 9 · standardAP
2026-01-24Labeling · Supplement 11 · standardAP
2026-01-24Labeling · Supplement 10 · standardAP
1999-10-15Manufacturing (CMC) · Supplement 7AP
1998-08-06Manufacturing (CMC) · Supplement 6AP
1997-06-23Manufacturing (CMC) · Supplement 5AP
1996-10-30Manufacturing (CMC) · Supplement 3AP
1996-10-30Manufacturing (CMC) · Supplement 4AP
1995-10-12Labeling · Supplement 2AP
1994-06-20Manufacturing (CMC) · Supplement 1AP
1993-12-21OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.