APPLICATION
ANDA218497
TYPE
ANDA
ORIGINAL APPROVAL
2024-06-12
LATEST ACTION
2026-06-25
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
NAPROXENPrescription
NAPROXEN 375MG · TABLET, DELAYED RELEASE · ORAL
NAPROXENPrescription
NAPROXEN 500MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2026-06-25Labeling · Supplement 4 · standardAP
2024-10-25Labeling · Supplement 1 · standardAP
2024-06-12UNKNOWN · Original · standardAP
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.