TheraRadar
Data updated: May 26, 2026

BACTRIM DS (sulfamethoxazole)

Cytochrome P450 2C9 Inhibitors
Infectious Disease Approved 1973-07-30

BACTRIM DS is indicated for the treatment of Urinary Tract Infection; Acute Otitis Media.

Source: FDA Label • Sun Pharma
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
3
Indications
--
Phase 3 Trials
52
Years on Market

Details

Status
Prescription
First Approved
1973-07-30
Routes
ORAL
Dosage Forms
TABLET

Companies

Sun Pharma
Active Ingredient: SULFAMETHOXAZOLE , TRIMETHOPRIM

BACTRIM DS Approval History

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Original
New Indication
New Form
Label Update
62 FDA actions from 1973 to 2025 · 2 indication expansions
Feb 2025 SUPPL
Label · Labeling
FDA Letter Label
Jun 2024 SUPPL
Label · Labeling
FDA Letter Label
Apr 2021 SUPPL
Label · Labeling
FDA Letter Label

What BACTRIM DS Treats

2 indications

BACTRIM DS 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

BACTRIM DS Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

CONTEPO
MEITHEAL
2025 2 indic.
BLUJEPA
GSK
2025 2 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to BACTRIM DS

3 of 20

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

BACTRIM
SULFAMETHOXAZOLE
2 shared
Sun Pharma
Shared indications:
Urinary Tract InfectionAcute Otitis Media
CEFUROXIME AXETIL
CEFUROXIME AXETIL
2 shared
Lupin
Shared indications:
Acute Otitis MediaUrinary Tract Infection
SULFATRIM PEDIATRIC
SULFAMETHOXAZOLE
2 shared
PHARM ASSOC
Shared indications:
Urinary Tract InfectionAcute Otitis Media
View all 20 similar drugs Pro
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT07561541 E26052 4983 Ph 4 recruiting Extended Oral Antibiotic Prophylaxis in Diabetic Fracture Patients
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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 DS FDA Label Details

Indications & Usage

FDA Label (PDF)

BACTRIM DS is indicated for the treatment of Urinary Tract Infection; Acute Otitis Media.

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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.