Vantin

NDA 50674, held by Pfizer. Cefpodoxime Proxetil.

As of Nov 13, 2026, NDA 50674 (Vantin), held by Pfizer, was first approved by FDA on Aug 7, 1992, with 13 approved supplements and 0 published complete response letters.

First approved: Aug 7, 1992
Review: Standard
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Nov 20, 1998	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Review
May 7, 1996	Supplement 5Efficacy (new indication or use)	Approved	None posted
Mar 14, 1996	Supplement 7Efficacy (new indication or use) · Standard review	Approved	None posted
May 28, 1993	Supplement 1Efficacy (new indication or use)	Approved	None posted
Aug 7, 1992	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
VantinEQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Cefpodoxime Proxetil	DiscontinuedReference drug
VantinEQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Cefpodoxime Proxetil	DiscontinuedReference drug

All 14 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 21, 2013	Supplement 15Labeling · Standard review	Approved	Label Letter
Jun 5, 2007	Supplement 14Labeling · Standard review	Approved	Label Letter
Jun 2, 2004	Supplement 13Labeling · Standard review	Approved	Letter Label
Nov 20, 1998	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Review
May 7, 1996	Supplement 5Efficacy (new indication or use)	Approved	None posted
Mar 14, 1996	Supplement 7Efficacy (new indication or use) · Standard review	Approved	None posted
Mar 14, 1996	Supplement 8Labeling · Standard review	Approved	None posted
Feb 7, 1996	Supplement 10Labeling · Standard review	Approved	None posted
Sep 28, 1995	Supplement 9Labeling · Standard review	Approved	None posted
Jul 6, 1994	Supplement 4Labeling · Standard review	Approved	None posted
Nov 2, 1993	Supplement 3Labeling · Standard review	Approved	None posted
May 28, 1993	Supplement 1Efficacy (new indication or use)	Approved	None posted
Apr 8, 1993	Supplement 2Labeling · Standard review	Approved	None posted
Aug 7, 1992	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 50674
Drugs@FDA: Overview at FDA
Company: Pfizer

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