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FDA NDA · NDA050622

SUPRAX

Sponsor: LEDERLE

APPLICATION
NDA050622
TYPE
NDA
ORIGINAL APPROVAL
1989-04-28
LATEST ACTION
2009-03-13
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

SUPRAX · ReferenceDiscontinued
CEFIXIME 100MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SUSPENSION · ORAL

Approval history

2009-03-13Labeling · Supplement 8AP
2009-03-13Labeling · Supplement 15 · standardAP
2009-03-13Labeling · Supplement 3AP
2009-03-13Labeling · Supplement 10AP
2004-05-18Labeling · Supplement 21 · standardAP
2004-03-29Labeling · Supplement 17 · standard — Label ↗AP
2003-08-20Labeling · Supplement 20 · standard — Label ↗AP
2002-08-06Manufacturing (CMC) · Supplement 18 · standardAP
2001-03-15Manufacturing (CMC) · Supplement 16 · standardAP
2001-02-06Labeling · Supplement 14 · standardAP
1998-02-27Labeling · Supplement 13 · standardAP
1994-03-09Manufacturing (CMC) · Supplement 12 · standardAP
1993-04-22Manufacturing (CMC) · Supplement 11 · standardAP
1993-01-19Labeling · Supplement 5AP
1992-09-10Manufacturing (CMC) · Supplement 9 · standardAP
1992-03-09Labeling · Supplement 7AP
1991-12-05Manufacturing (CMC) · Supplement 6 · standardAP
1991-06-25Manufacturing (CMC) · Supplement 4 · standardAP
1990-03-30Manufacturing (CMC) · Supplement 2 · standardAP
1989-05-31Labeling · Supplement 1AP
1989-04-28Type 3 - New Dosage Form · Original · standardAP
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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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