APPLICATION
ANDA090562
TYPE
ANDA
ORIGINAL APPROVAL
2010-11-19
LATEST ACTION
2026-03-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
MEFENAMIC ACIDPrescription
MEFENAMIC ACID 250MG · CAPSULE · ORAL
Approval history
2026-03-13Manufacturing (CMC) · Supplement 13 · unknownAP
2025-06-17Labeling · Supplement 11 · standardAP
2022-09-06Labeling · Supplement 8 · standardAP
2019-10-30Labeling · Supplement 6 · standardAP
2019-10-30Labeling · Supplement 4 · standardAP
2019-10-30Labeling · Supplement 7 · standardAP
2016-01-21Labeling · Supplement 1 · standardAP
2010-11-19OriginalAP
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.