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Data updated: Jun 28, 2026

SULFAMETHOXAZOLE AND TRIMETHOPRIM (sulfamethoxazole) · VISTA PHARMS

Cytochrome P450 2C9 Inhibitors
Infectious Disease Approved 1981-05-19

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.

NDA
Small Molecule
28
Indications
--
Phase 3 Trials
45
Years on Market

SULFAMETHOXAZOLE AND TRIMETHOPRIM Approval History

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Original
New Indication
New Form
Label Update
541 FDA actions from 1981 to 2026
Feb 2026 SUPPL
Label · Labeling
Apr 2025 SUPPL
Label · Labeling
Feb 2025 SUPPL
Label · Labeling

What SULFAMETHOXAZOLE AND TRIMETHOPRIM Treats

6 indications

SULFAMETHOXAZOLE AND TRIMETHOPRIM is approved for 6 conditions since its original approval in 1981. These indications span multiple therapeutic areas including oncology, immunology, and more.

Source: FDA Label

SULFAMETHOXAZOLE AND TRIMETHOPRIM Competitive Set

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Active Pipeline

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Key Completed Trials

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Trial Timeline

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.

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.