RADIOGENIX SYSTEM (technetium tc-99m sodium pertechnetate generator) · NORTHSTAR MEDICAL
RADIOGENIX SYSTEM is FDA-approved to treat 5 conditions (same as ULTRA-TECHNEKOW V4).
Details
- Status
- Discontinued
- First Approved
- 2018-02-08
- Routes
- INTRAVENOUS, INTRAVESICULAR, OPHTHALMIC
- Dosage Forms
- SOLUTION
RADIOGENIX SYSTEM Approval History
What RADIOGENIX SYSTEM Treats
5 indicationsRADIOGENIX SYSTEM is approved for 5 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Thyroid Imaging
- Salivary Gland Imaging
- Urinary Bladder Imaging
- Vesicoureteral Reflux
- Nasolacrimal Drainage System Imaging
Same approved indications as ULTRA-TECHNEKOW V4 (same active ingredient).
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.
RADIOGENIX SYSTEM FDA Label Details
Indications & Usage
FDA Label (PDF)RADIOGENIX SYSTEM is FDA-approved to treat 5 conditions — same approved indications as ULTRA-TECHNEKOW V4.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.