APPLICATION
ANDA091353
TYPE
ANDA
ORIGINAL APPROVAL
2011-09-20
LATEST ACTION
2022-09-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
NAPROXEN SODIUMOver-the-counter
NAPROXEN SODIUM 220MG · TABLET · ORAL
Approval history
2022-09-06Labeling · Supplement 19 · standardAP
2022-09-06Labeling · Supplement 21 · standardAP
2022-09-06Labeling · Supplement 16 · standardAP
2019-11-22Labeling · Supplement 13 · standardAP
2019-11-22Labeling · Supplement 8 · standardAP
2019-11-22Labeling · Supplement 10 · standardAP
2019-11-06Manufacturing (CMC) · Supplement 15 · unknownAP
2011-09-20OriginalAP
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.