SULFAMETHOXAZOLE AND TRIMETHOPRIM (sulfamethoxazole) · VISTA PHARMS
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets, USP 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.
Details
- Status
- Prescription
- First Approved
- 1981-05-19
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, SUSPENSION, INJECTABLE
Companies
SULFAMETHOXAZOLE AND TRIMETHOPRIM Approval History
What SULFAMETHOXAZOLE AND TRIMETHOPRIM Treats
6 indicationsSULFAMETHOXAZOLE AND TRIMETHOPRIM is approved for 6 conditions since its original approval in 1981. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Urinary Tract Infections
- Acute Otitis Media
- Acute Exacerbations of Chronic Bronchitis
- Shigellosis
- Pneumocystis jiroveci Pneumonia
- Traveler's Diarrhea
SULFAMETHOXAZOLE AND TRIMETHOPRIM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
SULFAMETHOXAZOLE AND TRIMETHOPRIM FDA Label Details
Indications & Usage
FDA Label (PDF)To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets, USP 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 therapy. Uri...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.