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FDA ANDA · ANDA065082

CEFPODOXIME PROXETIL

Sponsor: SUN PHARM INDS LTD

APPLICATION
ANDA065082
TYPE
ANDA
ORIGINAL APPROVAL
2002-05-31
LATEST ACTION
2008-04-25
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

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

Approval history

2008-04-25Labeling · Supplement 10AP
2004-07-12Labeling · Supplement 4AP
2002-05-31Original — Letter ↗AP
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.

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