APPLICATION
ANDA065409
TYPE
ANDA
ORIGINAL APPROVAL
2007-06-08
LATEST ACTION
2015-09-21
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription
Products
CEFPODOXIME PROXETILPrescription
CEFPODOXIME PROXETIL EQ 50MG BASE/5ML · FOR SUSPENSION · ORAL
CEFPODOXIME PROXETILPrescription
CEFPODOXIME PROXETIL EQ 100MG BASE/5ML · FOR SUSPENSION · ORAL
Approval history
2015-09-21Labeling · Supplement 4 · standardAP
2007-11-29Labeling · Supplement 1AP
2007-06-08OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.