INDOCYANINE GREEN
Details
- Status
- Prescription
- First Approved
- 2007-11-21
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
INDOCYANINE GREEN Approval History
What INDOCYANINE GREEN Treats
1 FDA approvalsOriginally approved for its first indication in 2007 .
- Other (1)
Other
(1 approval)- • Approved indication (Nov 2007)Letter
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
INDOCYANINE GREEN FDA Label Details
ProIndications & Usage
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 ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.