APPLICATION
NDA020142
TYPE
NDA
ORIGINAL APPROVAL
1993-11-24
LATEST ACTION
2021-04-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CATAFLAM · ReferenceDiscontinued
DICLOFENAC POTASSIUM 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CATAFLAM · ReferenceDiscontinued
DICLOFENAC POTASSIUM 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2014-11-24Manufacturing (CMC) · Supplement 26 · standardAP
2002-09-19Manufacturing (CMC) · Supplement 15 · standardAP
2002-03-11Manufacturing (CMC) · Supplement 14 · standardAP
2001-10-31Labeling · Supplement 6 · standardAP
2001-07-13Manufacturing (CMC) · Supplement 13 · standardAP
2000-09-15Manufacturing (CMC) · Supplement 12 · standardAP
2000-07-10Manufacturing (CMC) · Supplement 11 · standardAP
1999-04-22Manufacturing (CMC) · Supplement 9 · standardAP
1998-04-20Labeling · Supplement 5 · standardAP
1997-11-12Manufacturing (CMC) · Supplement 8 · standardAP
1997-05-16Manufacturing (CMC) · Supplement 7 · standardAP
1995-11-28Manufacturing (CMC) · Supplement 4 · standardAP
1995-07-28Labeling · Supplement 3 · standardAP
1995-01-11Manufacturing (CMC) · Supplement 1 · standardAP
1994-07-06Manufacturing (CMC) · Supplement 2 · 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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