Cefpodoxime Proxetil

ANDA 90031, held by Chartwell Rx. Cefpodoxime Proxetil.

As of Nov 15, 2026, ANDA 90031 (Cefpodoxime Proxetil), held by Chartwell Rx, was first approved by FDA on Jan 14, 2009, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 14, 2009
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jan 14, 2009	Original application	Approved	None posted

Products

2 strengths and forms


Cefpodoxime ProxetilEQ 50MG BASE/5ML · for suspension;oral	Cefpodoxime Proxetil	Discontinued
Cefpodoxime ProxetilEQ 100MG BASE/5ML · for suspension;oral	Cefpodoxime Proxetil	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jun 2, 2014	Supplement 5Labeling · Standard review	Approved	Label Letter
Jan 14, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 90031
Drugs@FDA: Overview at FDA
Company: Chartwell RX

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters