Vantin

NDA 50675, held by Pfizer. Cefpodoxime Proxetil.

As of Nov 13, 2026, NDA 50675 (Vantin), held by Pfizer, was first approved by FDA on Aug 7, 1992, with 18 approved supplements and 0 published complete response letters.

First approved: Aug 7, 1992
Review: Standard
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


Nov 20, 1998	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Review Letter
Nov 20, 1998	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Review Letter
May 7, 1996	Supplement 8Efficacy (new indication or use) · Standard review	Approved	None posted
Mar 14, 1996	Supplement 9Efficacy (new indication or use) · Standard review	Approved	None posted
Jun 16, 1995	Supplement 3Efficacy (new indication or use)	Approved	None posted
Aug 7, 1992	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


VantinEQ 50MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · for suspension;oral	Cefpodoxime Proxetil	DiscontinuedReference drug
VantinEQ 100MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · for suspension;oral	Cefpodoxime Proxetil	DiscontinuedReference drug

All 19 submissions, including labeling and manufacturing supplements


Jun 21, 2013	Supplement 18Labeling · Standard review	Approved	Label Letter
Jun 5, 2007	Supplement 17Labeling · Standard review	Approved	Letter Label
Jun 2, 2004	Supplement 16Labeling · Standard review	Approved	Letter Label
Nov 20, 1998	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Review Letter
Nov 20, 1998	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Review Letter
Mar 19, 1997	Supplement 13Labeling	Approved	None posted
Dec 9, 1996	Supplement 12Manufacturing · Standard review	Approved	None posted
May 7, 1996	Supplement 8Efficacy (new indication or use) · Standard review	Approved	None posted
Mar 14, 1996	Supplement 10Labeling · Standard review	Approved	None posted
Mar 14, 1996	Supplement 9Efficacy (new indication or use) · Standard review	Approved	None posted
Sep 28, 1995	Supplement 11Labeling · Standard review	Approved	None posted
Jun 16, 1995	Supplement 3Efficacy (new indication or use)	Approved	None posted
Jul 6, 1994	Supplement 7Labeling · Standard review	Approved	None posted
Nov 2, 1993	Supplement 6Labeling · Standard review	Approved	None posted
Oct 20, 1993	Supplement 5Labeling · Standard review	Approved	None posted
Oct 12, 1993	Supplement 1Labeling	Approved	None posted
Apr 22, 1993	Supplement 4Labeling · Standard review	Approved	None posted
Apr 8, 1993	Supplement 2Labeling · Standard review	Approved	None posted
Aug 7, 1992	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50675
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