Cefpodoxime Proxetil

ANDA 65388, held by Anda Repository. Cefpodoxime Proxetil.

As of Nov 15, 2026, ANDA 65388 (Cefpodoxime Proxetil), held by Anda Repository, was first approved by FDA on Nov 14, 2007, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 14, 2007
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
Nov 14, 2007	Original application	Approved	None posted

Products

2 strengths and forms


Cefpodoxime ProxetilEQ 100MG BASE · tablet;oral	Cefpodoxime Proxetil	Rx
Cefpodoxime ProxetilEQ 200MG BASE · tablet;oral	Cefpodoxime Proxetil	Rx

All 2 submissions, including labeling and manufacturing supplements


Oct 6, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Nov 14, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 65388
Drugs@FDA: Overview at FDA
Company: ANDA Repository

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