TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE (trimethobenzamide hydrochloride) · AM REGENT
TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE is FDA-approved to treat 3 conditions (same as TIGAN).
Details
- Status
- Discontinued
- First Approved
- 2011-03-08
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE Approval History
What TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE Treats
3 indicationsTRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE is approved for 3 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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
Indications & Usage
TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE is FDA-approved to treat 3 conditions — same approved indications as TIGAN.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.