Data updated: Mar 10, 2026
SODIUM IODIDE I 123
SODIUM IODIDE I-123
Metabolic
Approved 1976-03-24
3
Indications
--
Phase 3 Trials
1
Priority Reviews
49
Years on Market
Details
- Status
- Prescription
- First Approved
- 1976-03-24
- Routes
- ORAL
- Dosage Forms
- CAPSULE, SOLUTION
SODIUM IODIDE I 123 Approval History
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What SODIUM IODIDE I 123 Treats
3 FDA approvalsOriginally approved for its first indication in 1976 . Covers 3 distinct patient populations.
- Other (3)
Other
(3 approvals)- • Approved indication (Mar 1976) Priority
- • Approved indication (May 1982)
- • Approved indication (Feb 1989)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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 IODIDE I 123 FDA Label Details
ProIndications & Usage
FDA Label (PDF)Administration of Sodium Iodide I 123 Capsules is indicated as a diagnostic procedure to be used in evaluating thyroid function and/or morphology.
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Data Sources
FDA Approval: ANDA071910 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →
Data sourced from official FDA and NIH databases. Click links to verify on original sources.