APPLICATION
ANDA210016
TYPE
ANDA
ORIGINAL APPROVAL
2019-11-01
LATEST ACTION
2025-12-15
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
CLARISCANPrescription
GADOTERATE MEGLUMINE 1.8845GM/5ML (376.9MG/ML) · SOLUTION · INTRAVENOUS
CLARISCANPrescription
GADOTERATE MEGLUMINE 7.538GM/20ML (376.9MG/ML) · SOLUTION · INTRAVENOUS
CLARISCANPrescription
GADOTERATE MEGLUMINE 3.769GM/10ML (376.9MG/ML) · SOLUTION · INTRAVENOUS
CLARISCANPrescription
GADOTERATE MEGLUMINE 37.69GM/100ML (376.9MG/ML) · SOLUTION · INTRAVENOUS
CLARISCANPrescription
GADOTERATE MEGLUMINE 5.6535GM/15ML (376.9MG/ML) · SOLUTION · INTRAVENOUS
Approval history
2025-12-15Labeling · Supplement 22 · standardAP
2025-12-15Labeling · Supplement 20 · standardAP
2025-12-15Labeling · Supplement 19 · standardAP
2025-12-15Labeling · Supplement 21 · standardAP
2023-11-29Labeling · Supplement 7 · standardAP
2020-11-24Labeling · Supplement 3 · 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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