APPLICATION
ANDA215304
TYPE
ANDA
ORIGINAL APPROVAL
2022-04-11
LATEST ACTION
2022-04-11
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
GADOTERATE MEGLUMINEDiscontinued
GADOTERATE MEGLUMINE 37.69GM/100ML (376.9MG/ML) · SOLUTION · INTRAVENOUS
GADOTERATE MEGLUMINEDiscontinued
GADOTERATE MEGLUMINE 5.6535GM/15ML (376.9MG/ML) · SOLUTION · INTRAVENOUS
GADOTERATE MEGLUMINEDiscontinued
GADOTERATE MEGLUMINE 1.8845GM/5ML (376.9MG/ML) · SOLUTION · INTRAVENOUS
GADOTERATE MEGLUMINEDiscontinued
GADOTERATE MEGLUMINE 7.538GM/20ML (376.9MG/ML) · SOLUTION · INTRAVENOUS
GADOTERATE MEGLUMINEDiscontinued
GADOTERATE MEGLUMINE 3.769GM/10ML (376.9MG/ML) · SOLUTION · INTRAVENOUS
Approval history
2022-04-11UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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