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Data updated: Mar 10, 2026

AZACTAM

AZTREONAM
Infectious Disease Approved 1986-12-31
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
2
Indications
--
Phase 3 Trials
1
Priority Reviews
39
Years on Market

Details

Status
Prescription
First Approved
1986-12-31
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Bristol-Myers Squibb
Active Ingredient: AZTREONAM

AZACTAM Approval History

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What AZACTAM Treats

8 indications

AZACTAM is approved for 8 conditions since its original approval in 1986. 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 AZACTAM

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

AZTREONAM
AZTREONAM
8 shared
Pfizer
Shared indications:
Urinary Tract InfectionPyelonephritisCystitis +5 more
CEFUROXIME
CEFUROXIME
5 shared
Hikma
Shared indications:
Lower Respiratory Tract InfectionPneumoniaUrinary Tract Infection +2 more
TAZICEF
CEFTAZIDIME
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
CEFOXITIN SODIUM
3 shared
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
FLUCYTOSINE
2 shared
BAUSCH
Shared indications:
SepticemiaUrinary Tract Infection
AUGMENTIN '125'
AMOXICILLIN
2 shared
US ANTIBIOTICS
Shared indications:
Lower Respiratory Tract InfectionUrinary Tract Infection
AUGMENTIN '250'
AMOXICILLIN
2 shared
US ANTIBIOTICS
Shared indications:
Lower Respiratory Tract InfectionUrinary Tract Infection
AUGMENTIN '875'
AMOXICILLIN
2 shared
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.

AZACTAM FDA Label Details

Pro

Indications & Usage

FDA Label (PDF)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AZACTAM (aztreonam for injection, USP) and other antibacterial drugs, AZACTAM 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. AZACTAM is indicated for the treatment of the ...

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Data Sources

FDA Approval: NDA050580 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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