Gadoquatrane

FDA Drug Profile — Ambelvist

Gadoquatrane is listed in the FDA National Drug Code directory with 12 NDC codes, marketed under brand name including Ambelvist. Available dosage form: injection.

Drug Details

Generic Name
Gadoquatrane
Brand Names
Ambelvist
Application Number
NDA219627
Sponsor
Bayer HealthCare Pharmaceuticals Inc.
NDC Codes
12
Dosage Forms
INJECTION
Routes
INTRAVENOUS
Active Ingredients
GADOQUATRANE

Indications and Usage

1 INDICATIONS AND USAGE AMBELVIST is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues) the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) AMBELVIST is a gadolinium-based contrast agent indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues) the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) ( 1 )