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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215982
Company: HENGRUI PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GADOTERATE MEGLUMINE GADOTERATE MEGLUMINE 37.69GM/100ML (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
04/15/2022 ORIG-1 Approval STANDARD

Label is not available on this site.

GADOTERATE MEGLUMINE

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
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