TROPHAMINE
Details
- Status
- Prescription
- First Approved
- 1984-07-20
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
TROPHAMINE Approval History
What TROPHAMINE Treats
2 indicationsTROPHAMINE is approved for 2 conditions since its original approval in 1984. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Weight Loss
- Negative Nitrogen Balance
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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.
TROPHAMINE FDA Label Details
ProIndications & Usage
FDA Label (PDF)TrophAmine® is indicated for the nutritional support of infants (including those of low birth weight) and young pediatric patients requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with TrophAmine® is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young pediatric patients where the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is not feasible by these routes; gastrointestinal absorption of protein is impaired; or protein requirements a...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.