Cefuroxime Sodium

ANDA 64124, held by Acs Dobfar Spa. Cefuroxime Sodium.

As of Nov 15, 2026, ANDA 64124 (Cefuroxime Sodium), held by Acs Dobfar Spa, was first approved by FDA on May 30, 1997, with 7 approved supplements and 0 published complete response letters.

First approved: May 30, 1997
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
May 30, 1997	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cefuroxime SodiumEQ 7.5GM BASE/VIAL · injectable;injection	Cefuroxime Sodium	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Oct 8, 2021	Supplement 18Labeling · Standard review	Approved	None posted
Jul 31, 2008	Supplement 8Labeling	Approved	None posted
Nov 16, 2007	Supplement 7Labeling	Approved	None posted
Jun 20, 2007	Supplement 6Labeling	Approved	None posted
Jan 31, 2007	Supplement 5Labeling	Approved	None posted
Sep 30, 2004	Supplement 3Labeling	Approved	None posted
Sep 23, 1999	Supplement 1Manufacturing	Approved	None posted
May 30, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 64124
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