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Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

BACTRIM

SULFAMETHOXAZOLE Dihydrofolate Reductase Inhibitors
Infectious Disease Approved 1973-07-30
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
5
Indications
--
Phase 3 Trials
1
Priority Reviews
52
Years on Market

Details

Status
Prescription
First Approved
1973-07-30
Routes
ORAL, INJECTION
Dosage Forms
TABLET, SUSPENSION, INJECTABLE

Companies

Sun Pharma
Active Ingredient: SULFAMETHOXAZOLE , TRIMETHOPRIM

BACTRIM Approval History

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What BACTRIM Treats

2 indications

BACTRIM is approved for 2 conditions since its original approval in 1973. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Urinary Tract Infection
  • Acute Otitis Media
Source: FDA Label

Drugs Similar to BACTRIM

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

BACTRIM DS
SULFAMETHOXAZOLE
2 shared
Sun Pharma
Shared indications:
Urinary Tract InfectionAcute Otitis Media
CEFUROXIME AXETIL
CEFUROXIME AXETIL
2 shared
Aurobindo Pharma
Shared indications:
Acute Otitis MediaUrinary Tract Infection
SULFATRIM PEDIATRIC
SULFAMETHOXAZOLE
2 shared
PHARM ASSOC
Shared indications:
Urinary Tract InfectionAcute Otitis Media
TRIMETHOPRIM
TRIMETHOPRIM
2 shared
Dr. Reddy's
Shared indications:
Urinary Tract InfectionAcute Otitis Media
AMOXICILLIN PEDIATRIC
AMOXICILLIN
1 shared
Teva
Shared indications:
Urinary Tract Infection
AMPICILLIN SODIUM
AMPICILLIN SODIUM
1 shared
SAGENT PHARMS INC
Shared indications:
Urinary Tract Infection
ANCOBON
FLUCYTOSINE
1 shared
BAUSCH
Shared indications:
Urinary Tract Infection
ARIKAYCE KIT
AMIKACIN SULFATE
1 shared
INSMED INC
Shared indications:
Urinary Tract Infection
AUGMENTIN '125'
AMOXICILLIN
1 shared
US ANTIBIOTICS
Shared indications:
Urinary Tract Infection
AUGMENTIN '250'
AMOXICILLIN
1 shared
US ANTIBIOTICS
Shared indications:
Urinary Tract Infection
AUGMENTIN '875'
AMOXICILLIN
1 shared
US ANTIBIOTICS
Shared indications:
Urinary Tract Infection
AUGMENTIN ES-600
AMOXICILLIN
1 shared
US ANTIBIOTICS
Shared indications:
Acute Otitis Media
AUGMENTIN XR
AMOXICILLIN
1 shared
US ANTIBIOTICS
Shared indications:
Urinary Tract Infection
AZACTAM
AZTREONAM
1 shared
Bristol-Myers Squibb
Shared indications:
Urinary Tract Infection
AZITHROMYCIN
AZITHROMYCIN
1 shared
Aurobindo Pharma
Shared indications:
Acute Otitis Media
AZTREONAM
AZTREONAM
1 shared
Pfizer
Shared indications:
Urinary Tract Infection
BLUJEPA
GEPOTIDACIN MESYLATE
1 shared
GSK
Shared indications:
Urinary Tract Infection
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER
CEFEPIME HYDROCHLORIDE
1 shared
B BRAUN
Shared indications:
Urinary Tract Infection
CEFEPIME HYDROCHLORIDE
CEFEPIME HYDROCHLORIDE
1 shared
QILU ANTIBIOTICS
Shared indications:
Urinary Tract Infection
CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER
CEFEPIME HYDROCHLORIDE
1 shared
SAMSON MEDCL
Shared indications:
Urinary 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.

BACTRIM FDA Label Details

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Indications & Usage

FDA Label (PDF)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of BACTRIM (sulfamethoxazole and trimethoprim) tablets and other antibacterial drugs, BACTRIM (sulfamethoxazole and trimethoprim) tablets 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 empiric selection of th...

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Data Sources

FDA Approval: NDA017377 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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