TRALEMENT
Details
- Status
- Prescription
- First Approved
- 2020-07-02
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
Companies
TRALEMENT Approval History
What TRALEMENT Treats
1 FDA approvalsOriginally approved for its first indication in 2020 .
- Other (1)
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.
TRALEMENT FDA Label Details
ProIndications & Usage
FDA Label (PDF)Tralement ® is indicated in adult and pediatric patients weighing at least 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Tralement is a combination of trace elements (zinc sulfate, cupric sulfate, manganese sulfate and selenious acid) indicated in adult and pediatric patients weighing at least 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
TRALEMENT Patents & Exclusivity
Patents (30 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.