Data updated: Mar 10, 2026
TRIMETHOBENZAMIDE HYDROCHLORIDE
TRIMETHOBENZAMIDE HYDROCHLORIDE
Approved 1982-10-19
8
Indications
--
Phase 3 Trials
43
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1982-10-19
- Routes
- INJECTION, ORAL
- Dosage Forms
- INJECTABLE, CAPSULE
Companies
WATSON LABS BPI LABS SOLOPAK AM REGENT Sun Pharma HERITAGE PHARMA AVET Lupin SMITH AND NEPHEW Pfizer
Active Ingredient: TRIMETHOBENZAMIDE HYDROCHLORIDE
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TRIMETHOBENZAMIDE HYDROCHLORIDE Approval History
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What TRIMETHOBENZAMIDE HYDROCHLORIDE Treats
8 FDA approvalsOriginally approved for its first indication in 1982 . Covers 8 distinct patient populations.
- Other (8)
Other
(8 approvals)- • Approved indication (Oct 1982)
- • Approved indication (Dec 1982)
- • Approved indication (Apr 1987)
- • Approved indication (Aug 2003)
- • Approved indication (Aug 2003)
- • Approved indication (Mar 2011)
- • Approved indication (Nov 2023)
- • Approved indication (Oct 2025) New
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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.
TRIMETHOBENZAMIDE HYDROCHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.