APPLICATION
ANDA074211
TYPE
ANDA
ORIGINAL APPROVAL
1994-02-28
LATEST ACTION
1997-12-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NAPROXENDiscontinued
NAPROXEN 375MG · TABLET · ORAL
NAPROXENDiscontinued
NAPROXEN 500MG · TABLET · ORAL
NAPROXENDiscontinued
NAPROXEN 250MG · TABLET · ORAL
Approval history
1997-12-05Manufacturing (CMC) · Supplement 3AP
1997-03-27Labeling · Supplement 5AP
1996-08-28Manufacturing (CMC) · Supplement 4AP
1996-02-07Labeling · Supplement 2AP
1995-01-13Manufacturing (CMC) · Supplement 1AP
1994-02-28OriginalAP
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.