APPLICATION
NDA050621
TYPE
NDA
ORIGINAL APPROVAL
1989-04-28
LATEST ACTION
2009-03-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SUPRAX · ReferenceDiscontinued
CEFIXIME 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
SUPRAX · ReferenceDiscontinued
CEFIXIME 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2009-03-13Efficacy · Supplement 4AP
2009-03-13Labeling · Supplement 18AP
2009-03-13Efficacy · Supplement 16AP
2009-03-13Labeling · Supplement 22 · standardAP
2009-03-13Efficacy · Supplement 14AP
2009-03-13Efficacy · Supplement 20 · standardAP
2009-03-13Efficacy · Supplement 15AP
2009-03-13Labeling · Supplement 11AP
2004-05-18Labeling · Supplement 27 · standardAP
2002-08-16Manufacturing (CMC) · Supplement 24 · standardAP
1998-02-27Labeling · Supplement 21 · standardAP
1994-03-10Manufacturing (CMC) · Supplement 19 · standardAP
1993-02-05Efficacy · Supplement 10AP
1993-01-19Labeling · Supplement 8AP
1992-11-13Manufacturing (CMC) · Supplement 17 · standardAP
1992-09-10Manufacturing (CMC) · Supplement 13 · standardAP
1992-03-09Manufacturing (CMC) · Supplement 5 · standardAP
1992-02-28Manufacturing (CMC) · Supplement 12 · standardAP
1992-02-27Manufacturing (CMC) · Supplement 9 · standardAP
1991-06-25Manufacturing (CMC) · Supplement 2 · standardAP
1990-10-31Manufacturing (CMC) · Supplement 6 · standardAP
1990-07-12Manufacturing (CMC) · Supplement 7 · standardAP
1990-04-18Manufacturing (CMC) · Supplement 3 · standardAP
1989-05-31Labeling · Supplement 1AP
1989-04-28Type 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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