Data updated: May 26, 2026
TRIMPEX 200 (trimethoprim)
Infectious Disease
Approved 1980-05-30
1
Indication
--
Phase 3 Trials
45
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1980-05-30
- Routes
- ORAL
- Dosage Forms
- TABLET
TRIMPEX 200 Approval History
1981
1982
1983
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Original
New Indication
New Form
Label Update
13 FDA actions from 1980 to 1997
Jul 1997 SUPPL
Mfg · Manufacturing (CMC)
Jul 1990 SUPPL
Mfg · Manufacturing (CMC)
Apr 1989 SUPPL
Mfg · Manufacturing (CMC)
Aug 1983 SUPPL
Mfg
Jul 1983 SUPPL
Label
Jan 1983 SUPPL
Mfg
Nov 1982 SUPPL
Mfg
Jul 1982 SUPPL
Label
Oct 1981 SUPPL
Mfg
Apr 1981 SUPPL
Mfg
Oct 1980 SUPPL
Mfg
May 1980 ORIGINAL
Update
What TRIMPEX 200 Treats
1 FDA approvalsOriginally approved for its first indication in 1980 .
- Other (1)
Other
(1 approval)- • Approved indication (May 1980)
📋
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06709196 REINFORCE | 2024-514312-27-00 2024-514312-27-00 | Ph 4 | recruiting | Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis |
| NCT03746106 results posted | 13060 5R01DK108722-02 | Ph 4 | completed | The Effect of SLC19A3 Inhibition on the Pharmacokinetics of Thiamine |
| NCT03077711 results posted | EH16-216 | Ph 4 | completed | Methenamine Hippurate Versus Trimethoprim in the Prevention of Recurrent UTIs |
| NCT02188472 PENTRIOX | PEN1011 | Ph 1 | completed | Pentriox - Induction of Oxidative Stress |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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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.
TRIMPEX 200 FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.