TheraRadar
Data updated: May 26, 2026

TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE (trimethobenzamide hydrochloride)

Gastrointestinal Approved 2011-03-08
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
15
Years on Market

Details

Status
Discontinued
First Approved
2011-03-08
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

AM REGENT
Active Ingredient: TRIMETHOBENZAMIDE HYDROCHLORIDE

TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE Approval History

2012
2013
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2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2011 to 2011
Mar 2011 ORIGINAL
Update

What TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE Treats

1 FDA approvals

Originally approved for its first indication in 2011 .

  • Other (1)
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT02373072 B7601009 2014-004389-54 Ph 1 completed A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's Disease
NCT02262767 B7601007 2014-003631-19 Ph 1 completed A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 Co-administered With Trimethobenzamide Hydrochloride in Healthy Subjects
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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 PRESERVATIVE FREE FDA Label Details

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Data Sources

FDA Approval: ANDA091329 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.