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Data updated: May 26, 2026

INDIUM IN 111 OXYQUINOLINE (indium in-111 oxyquinoline)

Radiopharmaceutical Activity
Other Approved 1985-12-24

INDIUM IN 111 OXYQUINOLINE is indicated for the treatment of Abscess; Infection; Inflammation.

Source: FDA Label • BWXT ITG
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
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

Companies

BWXT ITG GE HEALTHCARE
Active Ingredient: INDIUM IN-111 OXYQUINOLINE

INDIUM IN 111 OXYQUINOLINE Approval History

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Original
New Indication
New Form
Label Update
19 FDA actions from 1985 to 2022
Dec 2022 SUPPL
Label · Labeling
FDA Letter Label
Jul 2018 ORIGINAL
Update
FDA Letter
Jul 2014 SUPPL Priority
Mfg · Manufacturing (CMC)

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

INDIUM IN 111 OXYQUINOLINE Competitive Set

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Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

BYQLOVI
HARROW EYE
2024 2 indic.
FLUOROMETHOLONE
DIFGEN PHARMS
2024 2 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Key Completed Trials

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Trial Timeline

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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

Indications & Usage

FDA Label (PDF)

INDIUM IN 111 OXYQUINOLINE is indicated for the treatment of Abscess; Infection; Inflammation.

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Data Sources

FDA Approval: ANDA202586 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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