GLOFIL-125
Details
- Status
- Prescription
- First Approved
- 1974-02-12
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
GLOFIL-125 Approval History
What GLOFIL-125 Treats
1 indicationsGLOFIL-125 is approved for 1 conditions since its original approval in 1974. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Renal Disease
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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.
GLOFIL-125 FDA Label Details
ProIndications & Usage
GLOFIL-125 (Sodium Iothalamate I-125 Injection) is indicated for evaluation of glomerular filtration in the diagnosis or monitoring of patients with renal disease.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.