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Data updated: Mar 10, 2026

INDIUM IN 111 OXYQUINOLINE

INDIUM IN-111 OXYQUINOLINE Radiopharmaceutical Activity
Immunology Approved 1985-12-24
2
Indications
--
Phase 3 Trials
1
Priority Reviews
40
Years on Market

Details

Status
Prescription
First Approved
1985-12-24
Routes
INJECTION
Dosage Forms
INJECTABLE

INDIUM IN 111 OXYQUINOLINE Approval History

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What INDIUM IN 111 OXYQUINOLINE Treats

3 indications

INDIUM IN 111 OXYQUINOLINE is approved for 3 conditions since its original approval in 1985. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Abscess
  • Infection
  • Inflammation
Source: FDA Label

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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.

INDIUM IN 111 OXYQUINOLINE FDA Label Details

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Indications & Usage

FDA Label (PDF)

Indium In 111 Oxyquinoline Solution is indicated for radiolabeling autologous leukocytes. Indium In 111 oxyquinoline labeled leukocytes may be used as an adjunct in the detection of inflammatory processes to which leukocytes migrate, such as those associated with abscesses or other infection, following reinjection and detection by appropriate imaging procedures. The degree of accuracy may vary with labeling techniques and with the size, location and nature of the inflammatory process. Indium In 111 oxyquinoline labeled leukocyte imaging is not the preferred technique for the initial evaluation...

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.