APPLICATION
NDA050675
TYPE
NDA
ORIGINAL APPROVAL
1992-08-07
LATEST ACTION
2013-06-21
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued
Products
VANTIN · ReferenceDiscontinued
CEFPODOXIME PROXETIL EQ 50MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SUSPENSION · ORAL
VANTIN · ReferenceDiscontinued
CEFPODOXIME PROXETIL EQ 100MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SUSPENSION · ORAL
Approval history
1997-03-19Labeling · Supplement 13AP
1996-12-09Manufacturing (CMC) · Supplement 12 · standardAP
1996-05-07Efficacy · Supplement 8 · standardAP
1996-03-14Efficacy · Supplement 9 · standardAP
1996-03-14Labeling · Supplement 10 · standardAP
1995-09-28Labeling · Supplement 11 · standardAP
1995-06-16Efficacy · Supplement 3 · unknownAP
1994-07-06Labeling · Supplement 7 · standardAP
1993-11-02Labeling · Supplement 6 · standardAP
1993-10-20Labeling · Supplement 5 · standardAP
1993-10-12Labeling · Supplement 1AP
1993-04-22Labeling · Supplement 4 · standardAP
1993-04-08Labeling · Supplement 2 · standardAP
1992-08-07Type 3 - New Dosage Form · 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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