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Data updated: Mar 10, 2026

CEFAZOLIN AND DEXTROSE

CEFAZOLIN SODIUM
Infectious Disease Approved 2000-07-27
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
5
Indications
--
Phase 3 Trials
1
Priority Reviews
25
Years on Market

Details

Status
Prescription
First Approved
2000-07-27
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

B BRAUN
Active Ingredient: CEFAZOLIN SODIUM

CEFAZOLIN AND DEXTROSE Approval History

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What CEFAZOLIN AND DEXTROSE Treats

8 indications

CEFAZOLIN AND DEXTROSE is approved for 8 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Respiratory Tract Infections
  • Urinary Tract Infections
  • Skin and Skin Structure Infections
  • Biliary Tract Infections
  • Bone and Joint Infections
  • Genital Infections
  • Septicemia
  • Endocarditis
Source: FDA Label

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Trial Timeline

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Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CEFAZOLIN AND DEXTROSE FDA Label Details

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Indications & Usage

FDA Label (PDF)

Cefazolin for Injection and 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: Respiratory tract infections Urinary tract infections Skin and skin structure infections Biliary tract infections Bone and joint infections Genital infections Septicemia Endocarditis Perioperative prophylaxis in adults and pediatric patients aged 10 to 17 years old for whom appropriate dosing with this ...

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Data Sources

FDA Approval: NDA050779 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.