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gadoterate meglumine

FDA Drug Profile — Gadoterate Meglumine, DOTAREM, gadoterate meglumine, CLARISCAN

Drug Details

Generic Name
gadoterate meglumine
Brand Names
Gadoterate Meglumine, DOTAREM, gadoterate meglumine, CLARISCAN
Application Number
ANDA215304
Sponsor
Fresenius Kabi USA, LLC
NDC Codes
14
Dosage Forms
INJECTION, INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
GADOTERATE MEGLUMINE

Indications and Usage

1 INDICATIONS AND USAGE DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity. DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.