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Data updated: Mar 10, 2026

AZTREONAM

AZTREONAM
Infectious Disease Approved 2010-06-18
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
4
Indications
--
Phase 3 Trials
15
Years on Market

Details

Status
Prescription
First Approved
2010-06-18
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Pfizer Hikma Fresenius Kabi
Active Ingredient: AZTREONAM

AZTREONAM Approval History

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What AZTREONAM Treats

8 indications

AZTREONAM is approved for 8 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Urinary Tract Infection
  • Pyelonephritis
  • Cystitis
  • Lower Respiratory Tract Infection
  • Pneumonia
  • Bronchitis
  • Septicemia
  • Skin and Skin-Structure Infection
Source: FDA Label

Drugs Similar to AZTREONAM

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

AZACTAM
AZTREONAM
8 shared
Bristol-Myers Squibb
Shared indications:
Urinary Tract InfectionPyelonephritisCystitis +5 more
CEFUROXIME
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5 shared
Hikma
Shared indications:
Lower Respiratory Tract InfectionPneumoniaUrinary Tract Infection +2 more
TAZICEF
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4 shared
Pfizer
Shared indications:
Lower Respiratory Tract InfectionPneumoniaSkin and Skin-Structure Infection +1 more
CEFEPIME HYDROCHLORIDE
CEFEPIME HYDROCHLORIDE
3 shared
QILU ANTIBIOTICS
Shared indications:
PneumoniaUrinary Tract InfectionPyelonephritis
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER
CEFOXITIN SODIUM
3 shared
B BRAUN
Shared indications:
Lower Respiratory Tract InfectionPneumoniaUrinary Tract Infection
CEFOXITIN IN PLASTIC CONTAINER
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SAMSON MEDCL
Shared indications:
Lower Respiratory Tract InfectionPneumoniaUrinary Tract Infection
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
NITROFURANTOIN
3 shared
Novartis
Shared indications:
Urinary Tract InfectionCystitisPyelonephritis
AMOXICILLIN PEDIATRIC
AMOXICILLIN
2 shared
Teva
Shared indications:
Lower Respiratory Tract InfectionUrinary Tract Infection
AMPICILLIN SODIUM
AMPICILLIN SODIUM
2 shared
SAGENT PHARMS INC
Shared indications:
SepticemiaUrinary Tract Infection
ANCOBON
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2 shared
BAUSCH
Shared indications:
SepticemiaUrinary Tract Infection
AUGMENTIN '125'
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US ANTIBIOTICS
Shared indications:
Lower Respiratory Tract InfectionUrinary Tract Infection
AUGMENTIN '250'
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2 shared
US ANTIBIOTICS
Shared indications:
Lower Respiratory Tract InfectionUrinary Tract Infection
AUGMENTIN '875'
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US ANTIBIOTICS
Shared indications:
Lower Respiratory Tract InfectionUrinary Tract Infection
AUGMENTIN XR
AMOXICILLIN
2 shared
US ANTIBIOTICS
Shared indications:
Lower Respiratory Tract InfectionUrinary Tract Infection
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER
CEFEPIME HYDROCHLORIDE
2 shared
B BRAUN
Shared indications:
PneumoniaUrinary Tract Infection
CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER
CEFEPIME HYDROCHLORIDE
2 shared
SAMSON MEDCL
Shared indications:
PneumoniaUrinary Tract Infection
CEFEPIME IN PLASTIC CONTAINER
CEFEPIME HYDROCHLORIDE
2 shared
Baxter
Shared indications:
PneumoniaUrinary Tract Infection
CEFOTAN
CEFOTETAN DISODIUM
2 shared
PAI HOLDINGS PHARM
Shared indications:
Urinary Tract InfectionLower Respiratory Tract Infection
DIFLUCAN
FLUCONAZOLE
2 shared
Pfizer
Shared indications:
Urinary Tract InfectionPneumonia
FIRVANQ KIT
VANCOMYCIN HYDROCHLORIDE
2 shared
AZURITY
Shared indications:
SepticemiaLower Respiratory Tract Infection
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

AZTREONAM FDA Label Details

Pro

Indications & Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of aztreonam for injection, USP and other antibacterial drugs, aztreonam for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Aztreonam for Injection is indicated for...

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Data Sources

FDA Approval: ANDA206517 → Label: DailyMed → Trials: ClinicalTrials.gov →

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