Kefurox

ANDA 62592, held by Lilly. Cefuroxime Sodium.

As of Nov 15, 2026, ANDA 62592 (Kefurox), held by Lilly, was first approved by FDA on Jan 10, 1986, with 18 approved supplements and 0 published complete response letters.

First approved: Jan 10, 1986
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Jan 10, 1986	Original application	Approved	None posted

Products

2 strengths and forms


KefuroxEQ 750MG BASE/VIAL · injectable;intravenous	Cefuroxime Sodium	Discontinued
KefuroxEQ 1.5GM BASE/VIAL · injectable;injection	Cefuroxime Sodium	Discontinued

All 19 submissions, including labeling and manufacturing supplements


Nov 12, 2002	Supplement 26Labeling	Approved	None posted
Nov 12, 2002	Supplement 24Labeling	Approved	None posted
Sep 30, 2002	Supplement 25Manufacturing	Approved	None posted
Sep 4, 2002	Supplement 23Manufacturing	Approved	None posted
Jun 24, 2002	Supplement 22Manufacturing	Approved	None posted
Sep 5, 2001	Supplement 21Manufacturing	Approved	None posted
Jan 22, 2001	Supplement 20Labeling	Approved	None posted
Jan 22, 2001	Supplement 19Manufacturing	Approved	None posted
Jan 22, 2001	Supplement 18Manufacturing	Approved	None posted
Jan 22, 2001	Supplement 17Manufacturing	Approved	None posted
Jan 23, 1997	Supplement 14Labeling	Approved	None posted
Jan 23, 1997	Supplement 12Manufacturing	Approved	None posted
Jan 13, 1997	Supplement 13Manufacturing	Approved	None posted
Aug 15, 1996	Supplement 15Manufacturing	Approved	None posted
Oct 30, 1992	Supplement 10Manufacturing	Approved	None posted
Jun 12, 1992	Supplement 9Labeling	Approved	None posted
Jun 12, 1992	Supplement 5Manufacturing	Approved	None posted
Jul 21, 1986	Supplement 1Manufacturing	Approved	None posted
Jan 10, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 62592
Drugs@FDA: Overview at FDA
Company: Lilly

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