Cefuroxime Sodium

ANDA 65001, held by Fresenius Kabi USA. Cefuroxime Sodium.

As of Nov 15, 2026, ANDA 65001 (Cefuroxime Sodium), held by Fresenius Kabi USA, was first approved by FDA on May 30, 2001, with 4 approved supplements and 0 published complete response letters.

First approved: May 30, 2001
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
May 30, 2001	Original application	Approved	Letter

Products

2 strengths and forms


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

All 5 submissions, including labeling and manufacturing supplements


Nov 10, 2011	Supplement 6Labeling	Approved	None posted
Feb 20, 2004	Supplement 4Labeling	Approved	None posted
Nov 12, 2002	Supplement 2Labeling	Approved	None posted
Mar 28, 2002	Supplement 1Manufacturing	Approved	None posted
May 30, 2001	Original application	Approved	Letter

Identifiers

Application: ANDA 65001
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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