Kefurox

ANDA 62591, held by Acs Dobfar. Cefuroxime Sodium.

As of Nov 15, 2026, ANDA 62591 (Kefurox), held by Acs Dobfar, was first approved by FDA on Jan 10, 1986, with 22 approved supplements and 0 published complete response letters.

First approved: Jan 10, 1986
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

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

Products

3 strengths and forms


KefuroxEQ 750MG BASE/VIAL · injectable;intramuscular, intravenous	Cefuroxime Sodium	Discontinued
KefuroxEQ 1.5GM BASE/VIAL · injectable;injection	Cefuroxime Sodium	Discontinued
KefuroxEQ 7.5GM BASE/VIAL · injectable;injection	Cefuroxime Sodium	Discontinued

All 23 submissions, including labeling and manufacturing supplements


Nov 12, 2002	Supplement 38Labeling	Approved	None posted
Nov 12, 2002	Supplement 37Labeling	Approved	None posted
Nov 12, 2002	Supplement 36Labeling	Approved	None posted
Nov 12, 2002	Supplement 35Labeling	Approved	None posted
Sep 4, 2002	Supplement 34Manufacturing	Approved	None posted
Sep 5, 2001	Supplement 33Manufacturing	Approved	None posted
Jan 22, 2001	Supplement 32Labeling	Approved	None posted
Jan 22, 2001	Supplement 31Manufacturing	Approved	None posted
Jan 22, 2001	Supplement 30Manufacturing	Approved	None posted
Jan 22, 2001	Supplement 29Manufacturing	Approved	None posted
Jan 20, 1999	Supplement 26Labeling	Approved	None posted
Jan 20, 1999	Supplement 25Manufacturing	Approved	None posted
Jan 23, 1997	Supplement 20Labeling	Approved	None posted
Jan 23, 1997	Supplement 18Manufacturing	Approved	None posted
Jan 13, 1997	Supplement 19Manufacturing	Approved	None posted
Aug 15, 1996	Supplement 24Manufacturing	Approved	None posted
Aug 15, 1996	Supplement 23Labeling	Approved	None posted
Aug 15, 1996	Supplement 22Manufacturing	Approved	None posted
Feb 3, 1994	Supplement 11Labeling	Approved	None posted
Jun 12, 1992	Supplement 16Labeling	Approved	None posted
Jun 12, 1992	Supplement 10Manufacturing	Approved	None posted
Dec 10, 1991	Supplement 15Labeling	Approved	None posted
Jan 10, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 62591
Drugs@FDA: Overview at FDA
Company: ACS Dobfar

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