APPLICATION
ANDA074121
TYPE
ANDA
ORIGINAL APPROVAL
1993-12-21
LATEST ACTION
2020-03-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NAPROXENDiscontinued
NAPROXEN 500MG · TABLET · ORAL
NAPROXENDiscontinued
NAPROXEN 250MG · TABLET · ORAL
NAPROXENDiscontinued
NAPROXEN 375MG · TABLET · ORAL
Approval history
2020-03-19Labeling · Supplement 24 · standardAP
2020-03-19Labeling · Supplement 22 · standardAP
2020-03-19Labeling · Supplement 23 · standardAP
2008-07-25Labeling · Supplement 19AP
2006-06-07Labeling · Supplement 14AP
1999-11-01Manufacturing (CMC) · Supplement 11AP
1999-04-22Manufacturing (CMC) · Supplement 10AP
1998-12-07Manufacturing (CMC) · Supplement 9AP
1998-02-05Manufacturing (CMC) · Supplement 8AP
1997-08-06Manufacturing (CMC) · Supplement 7AP
1996-04-16Labeling · Supplement 4AP
1996-04-04Manufacturing (CMC) · Supplement 6AP
1996-03-13Manufacturing (CMC) · Supplement 5AP
1995-12-15Manufacturing (CMC) · Supplement 3AP
1994-05-23Manufacturing (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.