Application Nr Approved Date Route Status External Links
NDA211580 None Intravascular None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Spy Agent™ Green Is An Optical Imaging Agent Indicated For Use With A Fluorescence Imaging Device For: Visualization Of Vessels (Micro And Macro Vasculature), Blood Flow And Tissue Perfusion Before, During, And After Vascular, Gastrointestinal, Organ Transplant, And Plastic, Micro- And Reconstructive Surgeries Including General Minimally Invasive Surgical Procedures In Adults And Pediatric Patients One Month Of Age And Older. ( 1.1 ) Visualization Of Extrahepatic Biliary Ducts In Adults And Pediatric Patients Aged 12 To 17 Years. ( 1.2 ) Visualization Of Lymph Nodes And Lymphatic Vessels During Lymphatic Mapping In Women With Cervical And Uterine Tumors. ( 1.3 ) 1.1 Visualization Of Vessels, Blood Flow And Tissue Perfusion Spy Agent™ Green Is Indicated In Adults And Pediatric Patients One Month Of Age And Older For: Fluorescence Imaging Of Micro- And Macro-Vasculature, Blood Flow And Tissue Perfusion Before, During And After Vascular, Gastrointestinal, Organ Transplant, And Plastic, Micro- And Reconstructive Surgeries, Including General Minimally Invasive Surgical Procedures. 1.2 Visualization Of Extrahepatic Biliary Ducts Spy Agent™ Green Is Indicated In Adults And Pediatric Patients Aged 12 To 17 Years For: Fluorescence Imaging Of Extrahepatic Biliary Ducts. 1.3 Visualization Of Lymph Nodes And Lymphatic Vessels During Lymphatic Mapping For Cervical And Uterine Tumors Spy Agent™ Green Is Indicated In Women For: Fluorescence Imaging Of Lymph Nodes And Delineation Of Lymphatic Vessels In The Cervix And Uterus During Lymphatic Mapping In Patients With Solid Tumors For Which This Procedure Is A Component Of Intraoperative Management.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Indocyanine Green

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