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Abbreviated New Drug Application (ANDA): 210016
Company: GE HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLARISCAN GADOTERATE MEGLUMINE 3.769GM/10ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
CLARISCAN GADOTERATE MEGLUMINE 5.6535GM/15ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
CLARISCAN GADOTERATE MEGLUMINE 7.538GM/20ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
CLARISCAN GADOTERATE MEGLUMINE 37.69GM/100ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
CLARISCAN GADOTERATE MEGLUMINE 1.8845GM/5ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/01/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210016Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/24/2020 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

CLARISCAN

SOLUTION;INTRAVENOUS; 3.769GM/10ML (376.9MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLARISCAN GADOTERATE MEGLUMINE 3.769GM/10ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210016 GE HEALTHCARE
DOTAREM GADOTERATE MEGLUMINE 3.769GM/10ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 204781 GUERBET
GADOTERATE MEGLUMINE GADOTERATE MEGLUMINE 3.769GM/10ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 215304 HENGRUI PHARMA

SOLUTION;INTRAVENOUS; 5.6535GM/15ML (376.9MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLARISCAN GADOTERATE MEGLUMINE 5.6535GM/15ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210016 GE HEALTHCARE
DOTAREM GADOTERATE MEGLUMINE 5.6535GM/15ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 204781 GUERBET
GADOTERATE MEGLUMINE GADOTERATE MEGLUMINE 5.6535GM/15ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 215304 HENGRUI PHARMA

SOLUTION;INTRAVENOUS; 7.538GM/20ML (376.9MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLARISCAN GADOTERATE MEGLUMINE 7.538GM/20ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210016 GE HEALTHCARE
DOTAREM GADOTERATE MEGLUMINE 7.538GM/20ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 204781 GUERBET
GADOTERATE MEGLUMINE GADOTERATE MEGLUMINE 7.538GM/20ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 215304 HENGRUI PHARMA

SOLUTION;INTRAVENOUS; 37.69GM/100ML (376.9MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLARISCAN GADOTERATE MEGLUMINE 37.69GM/100ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210016 GE HEALTHCARE
DOTAREM GADOTERATE MEGLUMINE 37.69GM/100ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 204781 GUERBET
GADOTERATE MEGLUMINE GADOTERATE MEGLUMINE 37.69GM/100ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 215982 HENGRUI PHARMA

SOLUTION;INTRAVENOUS; 1.8845GM/5ML (376.9MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLARISCAN GADOTERATE MEGLUMINE 1.8845GM/5ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210016 GE HEALTHCARE
DOTAREM GADOTERATE MEGLUMINE 1.8845GM/5ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 204781 GUERBET
GADOTERATE MEGLUMINE GADOTERATE MEGLUMINE 1.8845GM/5ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 215304 HENGRUI PHARMA
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