SODIUM FLUORIDE F-18
Details
- Status
- Prescription
- First Approved
- 2011-01-26
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
Companies
SODIUM FLUORIDE F-18 Approval History
What SODIUM FLUORIDE F-18 Treats
1 indicationsSODIUM FLUORIDE F-18 is approved for 1 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Altered Osteogenic Activity
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.
SODIUM FLUORIDE F-18 FDA Label Details
ProIndications & Usage
Sodium Fluoride F 18 Injection, USP is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity. Sodium Fluoride F 18 Injection, USP is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging of bone to define areas of altered osteogenic activity .
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.