APPLICATION
NDA015034
TYPE
NDA
ORIGINAL APPROVAL
1967-03-28
LATEST ACTION
2025-12-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
PONSTEL · ReferencePrescription
MEFENAMIC ACID 250MG · CAPSULE · ORAL
Approval history
2015-01-05Manufacturing (CMC) · Supplement 43 · standardAP
2009-08-03Manufacturing (CMC) · Supplement 41AP
2001-07-31Manufacturing (CMC) · Supplement 35 · standardAP
1998-09-01Manufacturing (CMC) · Supplement 33 · standardAP
1996-04-05Manufacturing (CMC) · Supplement 31 · standardAP
1993-10-04Manufacturing (CMC) · Supplement 29 · standardAP
1989-06-14Labeling · Supplement 28AP
1989-06-14Manufacturing (CMC) · Supplement 27 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 24 · standardAP
1984-08-13Manufacturing (CMC) · Supplement 23 · standardAP
1984-05-29Manufacturing (CMC) · Supplement 25 · standardAP
1983-04-19Manufacturing (CMC) · Supplement 22 · standardAP
1983-03-31Labeling · Supplement 21AP
1982-01-26Manufacturing (CMC) · Supplement 19 · standardAP
1981-05-14Manufacturing (CMC) · Supplement 15 · standardAP
1981-03-02Manufacturing (CMC) · Supplement 16 · standardAP
1981-02-17Labeling · Supplement 13AP
1981-02-17Manufacturing (CMC) · Supplement 12 · standardAP
1981-02-05Manufacturing (CMC) · Supplement 17 · standardAP
1981-01-29Manufacturing (CMC) · Supplement 14 · standardAP
1977-10-18Manufacturing (CMC) · Supplement 11 · standardAP
1977-04-27Manufacturing (CMC) · Supplement 10 · standardAP
1975-04-28Labeling · Supplement 8AP
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.
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