TheraRadar
Data updated: Mar 29, 2026

SPY AGENT GREEN KIT

INDOCYANINE GREEN
Gastroenterology Approved 2018-11-21

Indocyanine Green for Injection USP is indicated: Indocyanine Green for Injection USP a tricarbocyanine dye, is indicated: • For visual assessment of blood vessels, blood flow and related tissue perfusion with OLYMPUS infrared compatible endoscopic imaging system ( 1.1 ) • For visual assessment of the major extrahepatic bile ducts with OLYMPUS infrared imaging endoscopic imaging system ( 1.2 ) • For viewing intra-operative blood flow in the cerebral area with OLYMPUS infrared compatible video mi...

Source: FDA Label • NOVADAQ TECH
2
Indications
--
Phase 3 Trials
7
Years on Market

Details

Status
Prescription
First Approved
2018-11-21
Routes
INTRAVENOUS, INTERSTITIAL
Dosage Forms
POWDER

Companies

Active Ingredient: INDOCYANINE GREEN

SPY AGENT GREEN KIT Approval History

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What SPY AGENT GREEN KIT Treats

2 FDA approvals

Originally approved for its first indication in 2018 . Covers 2 distinct patient populations.

  • Other (2)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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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.

SPY AGENT GREEN KIT FDA Label Details

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Indications & Usage

FDA Label (PDF)

Indocyanine Green for Injection USP is indicated: Indocyanine Green for Injection USP a tricarbocyanine dye, is indicated: • For visual assessment of blood vessels, blood flow and related tissue perfusion with OLYMPUS infrared compatible endoscopic imaging system • For visual assessment of the major extrahepatic bile ducts with OLYMPUS infrared imaging endoscopic imaging system • For viewing intra-operative blood flow in the cerebral area with OLYMPUS infrared compatible video microscopic imaging system 1.1 Visual assessment of blood vessels, blood flow and related tissue perfusion For visual ...

SPY AGENT GREEN KIT Patents & Exclusivity

Latest Patent: Jul 2039
Exclusivity: Jun 2026

Patents (6 active)

US11712320 Expires Jul 14, 2039
US10631746 Expires Aug 4, 2035
US8406860 Expires Apr 9, 2029
US8647605 Expires Feb 11, 2029
US8185176 Expires Jun 4, 2028

Exclusivity

I-911 Until Jun 2026
Source: FDA Orange Book

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Data Sources

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