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FDA NDA · NDA050687

BANAN

Sponsor: SANKYO

APPLICATION
NDA050687
TYPE
NDA
ORIGINAL APPROVAL
1992-08-07
LATEST ACTION
2000-02-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

BANANDiscontinued
CEFPODOXIME PROXETIL EQ 100MG BASE · TABLET · ORAL
BANANDiscontinued
CEFPODOXIME PROXETIL EQ 200MG BASE · TABLET · ORAL

Approval history

2000-02-10Labeling · Supplement 8 · standard — Label ↗AP
2000-02-10Efficacy · Supplement 4 · standard — Letter ↗AP
2000-02-10Efficacy · Supplement 11 · standard — Review ↗AP
2000-02-10Labeling · Supplement 9 · standard — Review ↗AP
2000-02-10Efficacy · Supplement 7 · standard — Label ↗AP
2000-02-10Labeling · Supplement 12 · standard — Letter ↗AP
2000-02-10Efficacy · Supplement 10 · standard — Label ↗AP
1999-05-27Labeling · Supplement 5 · standardAP
1999-05-25Manufacturing (CMC) · Supplement 6 · standardAP
1997-12-22Efficacy · Supplement 1 · standardAP
1993-10-12Labeling · Supplement 2 · standardAP
1993-04-08Labeling · Supplement 3 · standardAP
1992-08-07Type 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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