Cefpodoxime Proxetil

ANDA 65083, held by Sun Pharm Inds Ltd. Cefpodoxime Proxetil.

As of Nov 15, 2026, ANDA 65083 (Cefpodoxime Proxetil), held by Sun Pharm Inds Ltd, was first approved by FDA on Aug 20, 2003, with 2 approved supplements and 0 published complete response letters.

First approved: Aug 20, 2003
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Aug 20, 2003	Original application	Approved	None posted

Products

2 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Apr 25, 2008	Supplement 10Labeling	Approved	None posted
Jul 12, 2004	Supplement 2Labeling	Approved	None posted
Aug 20, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 65083
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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