APPLICATION
ANDA218073
TYPE
ANDA
ORIGINAL APPROVAL
2024-06-17
LATEST ACTION
2024-06-17
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
GADOTERATE MEGLUMINEPrescription
GADOTERATE MEGLUMINE 37.69GM/100ML (376.9MG/ML) · SOLUTION · INTRAVENOUS
GADOTERATE MEGLUMINEPrescription
GADOTERATE MEGLUMINE 5.6535GM/15ML (376.9MG/ML) · SOLUTION · INTRAVENOUS
GADOTERATE MEGLUMINEPrescription
GADOTERATE MEGLUMINE 1.8845GM/5ML (376.9MG/ML) · SOLUTION · INTRAVENOUS
GADOTERATE MEGLUMINEPrescription
GADOTERATE MEGLUMINE 7.538GM/20ML (376.9MG/ML) · SOLUTION · INTRAVENOUS
GADOTERATE MEGLUMINEPrescription
GADOTERATE MEGLUMINE 3.769GM/10ML (376.9MG/ML) · SOLUTION · INTRAVENOUS
Approval history
2024-06-17UNKNOWN · 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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