Cefuroxime And Dextrose In Duplex Container

NDA 50780, held by B Braun. Cefuroxime Sodium.

As of Nov 14, 2026, NDA 50780 (Cefuroxime And Dextrose In Duplex Container), held by B Braun, was first approved by FDA on Feb 21, 2001, with 7 approved supplements and 0 published complete response letters.

First approved: Feb 21, 2001
Review: Standard
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Cefuroxime for Injection USP and Dextrose Injection USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: Lower Respiratory Tract Infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, and Escherichia coli. Urinary Tract Infections caused by Escherichia coli and Klebsiella spp.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Feb 21, 2001	Original applicationNew formulation or manufacturer · Standard review	Approved	Letter Label Review

Products

2 strengths and forms


Cefuroxime And Dextrose In Duplex ContainerEQ 750MG BASE/VIAL · injectable;injection	Cefuroxime Sodium	DiscontinuedReference drug
Cefuroxime And Dextrose In Duplex ContainerEQ 1.5GM BASE/VIAL · injectable;injection	Cefuroxime Sodium	DiscontinuedReference drug

All 8 submissions, including labeling and manufacturing supplements


Dec 5, 2020	Supplement 20Labeling · Standard review	Approved	Label Letter
May 1, 2015	Supplement 19Labeling · Standard review	Approved	Letter Label
Dec 12, 2013	Supplement 18Manufacturing · Standard review	Approved	None posted
Sep 10, 2007	Supplement 11Labeling · Standard review	Approved	Letter Label
May 6, 2005	Supplement 8Labeling · Standard review	Approved	Letter
Jun 29, 2004	Supplement 6Labeling · Standard review	Approved	Letter
Aug 18, 2003	Supplement 5Labeling · Standard review	Approved	Letter
Feb 21, 2001	Original applicationNew formulation or manufacturer · Standard review	Approved	Letter Label Review

Identifiers

Application: NDA 50780
Drugs@FDA: Overview at FDA
Company: B. Braun Medical

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