APPLICATION
ANDA071081
TYPE
ANDA
ORIGINAL APPROVAL
1986-09-03
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
MECLOFENAMATE SODIUMPrescription
MECLOFENAMATE SODIUM EQ 50MG BASE · CAPSULE · ORAL
MECLOFENAMATE SODIUMPrescription
MECLOFENAMATE SODIUM EQ 100MG BASE · CAPSULE · ORAL
Approval history
2024-11-21Labeling · Supplement 26 · standardAP
2021-04-28Labeling · Supplement 21 · standardAP
2016-05-09Labeling · Supplement 19 · standardAP
2015-09-04Labeling · Supplement 18 · standardAP
2002-10-09Manufacturing (CMC) · Supplement 12AP
2002-10-09Manufacturing (CMC) · Supplement 13AP
1998-02-05Manufacturing (CMC) · Supplement 11AP
1994-05-05Labeling · Supplement 10AP
1994-01-28Manufacturing (CMC) · Supplement 9AP
1992-08-05Labeling · Supplement 7AP
1990-01-31Manufacturing (CMC) · Supplement 6AP
1989-08-04Labeling · Supplement 5AP
1989-02-08Labeling · Supplement 4AP
1987-04-09Manufacturing (CMC) · Supplement 3AP
1986-11-05Manufacturing (CMC) · Supplement 2AP
1986-09-03OriginalAP
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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