Ceftin

NDA 50605, held by Glaxosmithkline. Cefuroxime Axetil.

As of Nov 14, 2026, NDA 50605 (Ceftin), held by Glaxosmithkline, was first approved by FDA on Dec 28, 1987, with 41 approved supplements and 0 published complete response letters.

First approved: Dec 28, 1987
Review: Standard
Supplements approved: 41
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 42 submissions below


Aug 24, 1999	Supplement 32Efficacy (new indication or use) · Standard review	Approved	Review Letter
Sep 17, 1997	Supplement 25Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 19, 1996	Supplement 17Efficacy (new indication or use)	Approved	None posted
Dec 6, 1996	Supplement 24Efficacy (new indication or use)	Approved	None posted
Mar 13, 1996	Supplement 7Efficacy (new indication or use)	Approved	None posted
Jan 31, 1992	Supplement 8Efficacy (new indication or use)	Approved	None posted
Dec 28, 1987	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

3 strengths and forms


CeftinEQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Cefuroxime Axetil	DiscontinuedReference drug
CeftinEQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Cefuroxime Axetil	DiscontinuedReference drug
CeftinEQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Cefuroxime Axetil	DiscontinuedReference drug

All 42 submissions, including labeling and manufacturing supplements


Mar 5, 2021	Supplement 52Labeling · Standard review	Approved	Letter Label
Apr 25, 2019	Supplement 51Labeling · Standard review	Approved	Letter Label
Oct 13, 2017	Supplement 50Labeling · Standard review	Approved	Letter Label
Nov 22, 2016	Supplement 49Labeling · Standard review	Approved	Label Letter
Aug 26, 2015	Supplement 48Labeling · Standard review	Approved	Letter Label
Jun 26, 2015	Supplement 47Labeling · Standard review	Approved	Letter Label
Sep 20, 2014	Supplement 46Labeling · Standard review	Approved	Letter Label
Sep 20, 2014	Supplement 43Labeling · Standard review	Approved	Letter Label
Jul 23, 2007	Supplement 42Labeling · Standard review	Approved	Letter Label
Jun 3, 2004	Supplement 39Labeling · Standard review	Approved	Label Letter
Jul 24, 2002	Supplement 37Labeling · Standard review	Approved	Letter
Apr 11, 2002	Supplement 33Labeling · Standard review	Approved	Letter Label
Mar 29, 2002	Supplement 31Labeling · Standard review	Approved	Letter Label
Dec 20, 2001	Supplement 36Manufacturing · Standard review	Approved	None posted
Jul 3, 2001	Supplement 34Manufacturing · Standard review	Approved	None posted
Apr 13, 2001	Supplement 35Manufacturing · Standard review	Approved	None posted
Aug 24, 1999	Supplement 32Efficacy (new indication or use) · Standard review	Approved	Review Letter
Mar 24, 1998	Supplement 30Labeling · Standard review	Approved	None posted
Jan 16, 1998	Supplement 29Manufacturing · Standard review	Approved	None posted
Nov 19, 1997	Supplement 28Manufacturing · Standard review	Approved	None posted
Sep 17, 1997	Supplement 25Efficacy (new indication or use) · Standard review	Approved	None posted
Jun 4, 1997	Supplement 27Labeling · Standard review	Approved	None posted
Dec 23, 1996	Supplement 26Labeling · Standard review	Approved	None posted
Dec 23, 1996	Supplement 21Labeling · Standard review	Approved	None posted
Dec 19, 1996	Supplement 17Efficacy (new indication or use)	Approved	None posted
Dec 6, 1996	Supplement 24Efficacy (new indication or use)	Approved	None posted
Sep 13, 1996	Supplement 23Labeling · Standard review	Approved	None posted
Sep 13, 1996	Supplement 22Labeling · Standard review	Approved	None posted
Mar 13, 1996	Supplement 7Efficacy (new indication or use)	Approved	None posted
Aug 30, 1995	Supplement 20Manufacturing · Standard review	Approved	None posted
Jun 30, 1994	Supplement 19Labeling · Standard review	Approved	None posted
Oct 18, 1993	Supplement 15Labeling	Approved	None posted
Jun 28, 1993	Supplement 16Manufacturing · Standard review	Approved	None posted
Jan 27, 1993	Supplement 13Labeling	Approved	None posted
Jan 27, 1993	Supplement 11Labeling	Approved	None posted
Jan 31, 1992	Supplement 14Manufacturing · Standard review	Approved	None posted
Jan 31, 1992	Supplement 8Efficacy (new indication or use)	Approved	None posted
Aug 19, 1991	Supplement 9Labeling	Approved	None posted
Aug 19, 1991	Supplement 6Labeling	Approved	None posted
Aug 19, 1991	Supplement 5Labeling	Approved	None posted
Aug 9, 1991	Supplement 12Manufacturing · Standard review	Approved	None posted
Dec 28, 1987	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 50605
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