Cefazolin In Dextrose

NDA 207131, held by Baxter Hlthcare Corp. Cefazolin Sodium.

As of Nov 13, 2026, NDA 207131 (Cefazolin In Dextrose), held by Baxter Hlthcare Corp, was first approved by FDA on Aug 7, 2015, with 8 approved supplements and 0 published complete response letters.

First approved: Aug 7, 2015
Review: Standard
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Cefazolin in Dextrose Injection is a cephalosporin antibacterial indicated for:

Treatment of the following infections caused by susceptible isolates of the designated microorganisms in adult and pediatric patients for whom appropriate dosing with this formulation can be achieved: ο Respiratory tract infections; ο Urinary tract infections; ο Skin and skin structure infections; ο Biliary tract infections; ο Bone and joint infections; ο Genital infections; ο Septicemia; ο Endocarditis
Perioperative prophylaxis in adults and pediatric patients aged 10 to 17 years old for whom appropriate dosing with this formulation can be achieved To reduce the development of drug-resistant bacteria and mai…

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below


May 31, 2024	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 1, 2024	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 1, 2021	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 7, 2015	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Label Letter

Products

3 strengths and forms


Cefazolin In DextroseEQ 2GM BASE/100ML (EQ 20MG BASE/ML) · solution;intravenous	Cefazolin Sodium	RxReference drug
Cefazolin In DextroseEQ 1GM BASE/50ML (EQ 20MG BASE/ML) · solution;intravenous	Cefazolin Sodium	RxReference drug
Cefazolin In DextroseEQ 3GM BASE/150ML (EQ 20MG BASE/ML) · solution;intravenous	Cefazolin Sodium	RxReference drug

All 9 submissions, including labeling and manufacturing supplements


Aug 31, 2026	Supplement 14Labeling · Standard review	Approved	Letter Label
May 31, 2024	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 1, 2024	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 20, 2021	Supplement 8Labeling · Standard review	Approved	Label
Feb 1, 2021	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 11, 2016	Supplement 3Labeling · Standard review	Approved	Label Letter
Aug 1, 2016	Supplement 2Manufacturing · Standard review	Approved	None posted
May 25, 2016	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 7, 2015	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 207131
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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