APPLICATION
NDA018006
TYPE
NDA
ORIGINAL APPROVAL
1980-06-25
LATEST ACTION
1990-07-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
MECLOMENDiscontinued
MECLOFENAMATE SODIUM EQ 50MG BASE · CAPSULE · ORAL
MECLOMENDiscontinued
MECLOFENAMATE SODIUM EQ 100MG BASE · CAPSULE · ORAL
Approval history
1990-07-23Efficacy · Supplement 13AP
1990-07-23Efficacy · Supplement 11AP
1990-05-14Manufacturing (CMC) · Supplement 19 · standardAP
1989-01-09Labeling · Supplement 18AP
1988-08-30Efficacy · Supplement 9AP
1988-06-07Manufacturing (CMC) · Supplement 17 · standardAP
1987-12-10Labeling · Supplement 14AP
1985-11-20Labeling · Supplement 12AP
1985-05-15Manufacturing (CMC) · Supplement 10 · standardAP
1983-04-09Manufacturing (CMC) · Supplement 8 · standardAP
1983-02-13Manufacturing (CMC) · Supplement 5 · standardAP
1982-05-10Manufacturing (CMC) · Supplement 4 · standardAP
1981-11-22Labeling · Supplement 3AP
1981-04-11Manufacturing (CMC) · Supplement 2 · standardAP
1980-10-06Manufacturing (CMC) · Supplement 1 · standardAP
1980-06-25Type 1 - New Molecular Entity · 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.
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