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Data updated: Mar 10, 2026

TECHNETIUM TC-99M SULFUR COLLOID KIT

TECHNETIUM TC-99M SULFUR COLLOID KIT
Oncology Approved 2023-11-09
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
2
Years on Market

Details

Status
Prescription
First Approved
2023-11-09
Routes
INJECTION, ORAL
Dosage Forms
SOLUTION

Companies

JUBILANT
Active Ingredient: TECHNETIUM TC-99M SULFUR COLLOID KIT

TECHNETIUM TC-99M SULFUR COLLOID KIT Approval History

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What TECHNETIUM TC-99M SULFUR COLLOID KIT Treats

4 indications

TECHNETIUM TC-99M SULFUR COLLOID KIT is approved for 4 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Breast Cancer
  • Melanoma
  • Gastroesophageal Reflux
  • Pulmonary Aspiration
Source: FDA Label

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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.

TECHNETIUM TC-99M SULFUR COLLOID KIT FDA Label Details

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Indications & Usage

Technetium Tc 99m Sulfur Colloid Injection is indicated: In adults, to assist in the: Localization of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma when used with a hand-held gamma counter. Evaluation of peritoneo-venous (LeVeen) shunt patency. In adults and pediatric patients, for imaging: Areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow. Studies of esophageal transit and gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents. Technetium Tc 99m Sulfur Colloid Injection is a radioactive d...

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Data Sources

FDA Approval: ANDA213516 → Label: DailyMed → Trials: ClinicalTrials.gov →

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