Data updated: Mar 10, 2026
SULFAMETHOXAZOLE AND TRIMETHOPRIM
SULFAMETHOXAZOLE
Approved 1981-05-19
28
Indications
--
Phase 3 Trials
44
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1981-05-19
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, INJECTABLE, SUSPENSION
Companies
FOSUN PHARMA SOMERSET MUTUAL PHARM Hikma WATSON LABS ANI PHARMS USL PHARMA BEDFORD Aurobindo Pharma INTERPHARM VISTA PHARMS Teva PLIVA ABRAXIS PHARM Sun Pharma MARTEC USA LLC Pfizer GLENMARK PHARMS LTD ROXANE CHARTWELL MOLECULAR AIPING PHARM INC PRASCO Lupin AMNEAL PHARMS NY CHARTWELL MOLECULES HEATHER PHARMOBEDIENT NOVITIUM PHARMA
Website: ↗
SULFAMETHOXAZOLE AND TRIMETHOPRIM Approval History
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What SULFAMETHOXAZOLE AND TRIMETHOPRIM Treats
28 FDA approvalsOriginally approved for its first indication in 1981 . Covers 28 distinct patient populations.
- Other (28)
Other
(28 approvals)- • Approved indication (May 1981)
- • Approved indication (May 1982)
- • Approved indication (Jan 1983)
- • Approved indication (May 1983)
- • Approved indication (Nov 1984)
- • Approved indication (Nov 1984)
- • Approved indication (Nov 1984)
- • Approved indication (Sep 1985)
- • Approved indication (Oct 1985)
- • Approved indication (Aug 1986)
- • Approved indication (Nov 1986)
- • Approved indication (Apr 1987)
- • Approved indication (Aug 1991)
- • Approved indication (Oct 1991)
- • Approved indication (Sep 1992)
- • Approved indication (Dec 1997)
- • Approved indication (Jan 2005)
- • Approved indication (Oct 2005)
- • Approved indication (Nov 2006)
- • Approved indication (Jan 2007)
- • Approved indication (Jan 2007)
- • Approved indication (Feb 2010)
- • Approved indication (Jun 2010)
- • Approved indication (Dec 2010)
- • Approved indication (Aug 2017)
- • Approved indication (Jun 2019)
- • Approved indication (Jan 2021)
- • Approved indication (Feb 2022)
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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.
SULFAMETHOXAZOLE AND TRIMETHOPRIM FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.