← FDA DRUG APPROVALS

FDA NDA · NDA050688

BANAN

Sponsor: SANKYO

APPLICATION
NDA050688
TYPE
NDA
ORIGINAL APPROVAL
1992-08-07
LATEST ACTION
2000-02-10
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

BANANDiscontinued
CEFPODOXIME PROXETIL EQ 50MG BASE/5ML · FOR SUSPENSION · ORAL
BANANDiscontinued
CEFPODOXIME PROXETIL EQ 100MG BASE/5ML · FOR SUSPENSION · ORAL

Approval history

2000-02-10Efficacy · Supplement 8 · standard — Review ↗AP
2000-02-10Efficacy · Supplement 6 · standard — Label ↗AP
2000-02-10Efficacy · Supplement 12 · standard — Label ↗AP
2000-02-10Labeling · Supplement 10 · standard — Review ↗AP
2000-02-10Labeling · Supplement 9 · standard — Label ↗AP
2000-02-10Labeling · Supplement 13 · standard — Review ↗AP
2000-02-10Efficacy · Supplement 11 · standard — Label ↗AP
1999-05-27Labeling · Supplement 7 · standardAP
1999-05-26Labeling · Supplement 5 · standardAP
1997-12-22Efficacy · Supplement 1 · standardAP
1995-06-16Efficacy · Supplement 4 · standardAP
1993-10-12Labeling · Supplement 2 · standardAP
1993-04-08Labeling · Supplement 3 · standardAP
1992-08-07Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →