APPLICATION
ANDA075227
TYPE
ANDA
ORIGINAL APPROVAL
1998-06-30
LATEST ACTION
2019-11-06
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
NAPROXENPrescription
NAPROXEN 500MG · TABLET, DELAYED RELEASE · ORAL
NAPROXENPrescription
NAPROXEN 375MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2019-11-06Labeling · Supplement 18 · standardAP
2019-11-06Labeling · Supplement 20 · standardAP
2019-11-06Labeling · Supplement 17 · standardAP
2015-09-02Labeling · Supplement 12 · standardAP
2008-04-25Labeling · Supplement 9AP
2006-05-19Labeling · Supplement 8AP
2006-02-17Labeling · Supplement 7AP
1999-12-02Manufacturing (CMC) · Supplement 2AP
1999-12-02Manufacturing (CMC) · Supplement 3AP
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.