Ceftin

NDA 50672, held by Glaxosmithkline. Cefuroxime Axetil.

As of Nov 14, 2026, NDA 50672 (Ceftin), held by Glaxosmithkline, was first approved by FDA on Jun 30, 1994, with 31 approved supplements and 0 published complete response letters.

First approved: Jun 30, 1994
Review: Standard
Supplements approved: 31
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 32 submissions below


Aug 24, 1999	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Review Letter
Jun 30, 1994	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


CeftinEQ 125MG BASE/5ML · for suspension;oral	Cefuroxime Axetil	DiscontinuedReference drug
CeftinEQ 250MG BASE/5ML · for suspension;oral	Cefuroxime Axetil	DiscontinuedReference drug

All 32 submissions, including labeling and manufacturing supplements


Mar 5, 2021	Supplement 38Labeling · Standard review	Approved	Letter Label
Apr 25, 2019	Supplement 37Labeling · Standard review	Approved	Letter
Oct 13, 2017	Supplement 36Labeling · Standard review	Approved	Letter Label
Nov 22, 2016	Supplement 35Labeling · Standard review	Approved	Label Letter
Aug 26, 2015	Supplement 34Labeling · Standard review	Approved	Letter Label
Jun 26, 2015	Supplement 33Labeling · Standard review	Approved	Letter Label
Sep 20, 2014	Supplement 29Labeling · Standard review	Approved	Letter Label
Sep 20, 2014	Supplement 32Labeling · Standard review	Approved	Letter Label
Aug 1, 2007	Supplement 28Labeling · Standard review	Approved	Letter Label
Jun 3, 2004	Supplement 25Labeling · Standard review	Approved	Letter Label
Apr 11, 2002	Supplement 18Labeling · Standard review	Approved	Label Letter
Mar 29, 2002	Supplement 13Labeling · Standard review	Approved	Letter Label
Sep 18, 2001	Supplement 21Manufacturing · Standard review	Approved	None posted
Jul 3, 2001	Supplement 19Manufacturing · Standard review	Approved	None posted
Apr 13, 2001	Supplement 20Manufacturing · Standard review	Approved	None posted
Sep 25, 2000	Supplement 17Manufacturing · Standard review	Approved	None posted
Aug 24, 1999	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Review Letter
Jul 27, 1999	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 23, 1999	Supplement 16Manufacturing · Standard review	Approved	None posted
Mar 2, 1999	Supplement 15Manufacturing · Standard review	Approved	None posted
Mar 24, 1998	Supplement 12Labeling · Standard review	Approved	None posted
Nov 19, 1997	Supplement 11Manufacturing · Standard review	Approved	None posted
Jun 4, 1997	Supplement 10Labeling · Standard review	Approved	None posted
Apr 29, 1997	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 23, 1996	Supplement 4Labeling · Standard review	Approved	None posted
Dec 23, 1996	Supplement 9Labeling · Standard review	Approved	None posted
Sep 13, 1996	Supplement 1Labeling · Standard review	Approved	None posted
Sep 13, 1996	Supplement 5Labeling · Standard review	Approved	None posted
Dec 14, 1995	Supplement 2Labeling	Approved	None posted
Nov 9, 1995	Supplement 7Labeling · Standard review	Approved	None posted
Aug 8, 1995	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 30, 1994	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50672
Drugs@FDA: Overview at FDA
Company: GlaxoSmithKline LLC

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