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DOTAREM (nda204781)- (1.8845GM/5ML (376.9MG/ML),3.769GM/10ML (376.9MG/ML),5.6535GM/15ML (376.9MG/ML),7.538GM/20ML (376.9MG/ML),37.69GM/100ML (376.9MG/ML))

GADOTERATE MEGLUMINE GUERBET
1.8845GM/5ML (376.9MG/ML),3.769GM/10ML (376.9MG/ML),5.6535GM/15ML (376.9MG/ML),7.538GM/20ML (376.9MG/ML),37.69GM/100ML (376.9MG/ML)
No No
Expired 2018-Mar-20
None None
None No
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.
2 0 2
Total Other Developers 1
Drugs with Suitability No
1.8845GM/5ML (376.9MG/ML) ** ** - - -
3.769GM/10ML (376.9MG/ML) ** ** - - -
5.6535GM/15ML (376.9MG/ML) ** ** - - -
7.538GM/20ML (376.9MG/ML) ** ** - - -
37.69GM/100ML (376.9MG/ML) ** ** - - -
NDA Sales Available Total Generic Sales Available
No 1
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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