BONTRIL PDM
Details
- Status
- Prescription
- First Approved
- 1976-12-22
- Routes
- ORAL
- Dosage Forms
- TABLET
BONTRIL PDM Approval History
What BONTRIL PDM Treats
1 indicationsBONTRIL PDM is approved for 1 conditions since its original approval in 1976. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Obesity
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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.
BONTRIL PDM FDA Label Details
ProIndications & Usage
Phendimetrazine tartrate is indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m 2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follow: pounds ÷ 2.2 = kg; ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.