APPLICATION
ANDA074129
TYPE
ANDA
ORIGINAL APPROVAL
1993-12-21
LATEST ACTION
2000-09-27
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
2000-09-27Manufacturing (CMC) · Supplement 11AP
1998-09-18Manufacturing (CMC) · Supplement 10AP
1998-09-18Manufacturing (CMC) · Supplement 9AP
1998-09-18Manufacturing (CMC) · Supplement 8AP
1997-01-14Manufacturing (CMC) · Supplement 7AP
1997-01-14Manufacturing (CMC) · Supplement 6AP
1996-03-05Labeling · Supplement 2AP
1996-03-05Manufacturing (CMC) · Supplement 3AP
1996-03-05Manufacturing (CMC) · Supplement 1AP
1995-11-14Manufacturing (CMC) · Supplement 5AP
1995-08-24Manufacturing (CMC) · Supplement 4AP
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.