Cefuroxime Sodium

ANDA 65483, held by Hospira Inc. Cefuroxime Sodium.

As of Nov 15, 2026, ANDA 65483 (Cefuroxime Sodium), held by Hospira Inc, was first approved by FDA on Oct 15, 2008, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 15, 2008
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Oct 15, 2008	Original application	Approved	None posted

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 2 submissions, including labeling and manufacturing supplements


Apr 12, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Oct 15, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 65483
Drugs@FDA: Overview at FDA
Company: Hospira

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