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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215304
Company: HENGRUI PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GADOTERATE MEGLUMINE GADOTERATE MEGLUMINE 1.8845GM/5ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
GADOTERATE MEGLUMINE GADOTERATE MEGLUMINE 3.769GM/10ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
GADOTERATE MEGLUMINE GADOTERATE MEGLUMINE 5.6535GM/15ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
GADOTERATE MEGLUMINE GADOTERATE MEGLUMINE 7.538GM/20ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
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
04/11/2022 ORIG-1 Approval STANDARD

Label is not available on this site.

GADOTERATE MEGLUMINE

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

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 215304 HENGRUI PHARMA
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