Indocyanine Green and Water

FDA Drug Profile — Indocyanine Green

Drug Details

Generic Name
Indocyanine Green and Water
Brand Names
Indocyanine Green
Application Number
ANDA040811
Sponsor
Renew Pharmaceuticals Limited
NDC Codes
3
Dosage Forms
KIT
Routes
N/A
Active Ingredients
N/A

Indications and Usage

1 INDICATIONS AND 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 ( 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 microscopic imaging system ( 1.3 ) 1.1 Visual assessment of blood vessels, blood flow and related tissue perfusion For visual assessment of blood vessels, blood flow and related tissue perfusion with OLYMPUS infrared compatible endoscopic imaging system 1.2 Visual assessment of the major extrahepatic bile duct For visual assessment of the major extrahepatic bile ducts with OLYMPUS infrared imaging endoscopic imaging system. 1.3 Viewing intra-operative blood flow in the cerebral area For viewing intra-operative blood flow in the cerebral area with OLYMPUS infrared compatible video microscopic imaging system