← FDA DRUG APPROVALS

FDA ANDA · ANDA090031

CEFPODOXIME PROXETIL

Sponsor: CHARTWELL RX

APPLICATION
ANDA090031
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-14
LATEST ACTION
2014-06-02
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

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

Approval history

2014-06-02Labeling · Supplement 5 · standard — Label ↗AP
2009-01-14OriginalAP
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 →