Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215304
Company: HENGRUI PHARMA
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 | 218073 | HAINAN POLY |
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 | 218073 | HAINAN POLY |
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 | 218073 | HAINAN POLY |
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 | 218073 | HAINAN POLY |
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 | 218073 | HAINAN POLY |
GADOTERATE MEGLUMINE | GADOTERATE MEGLUMINE | 37.69GM/100ML (376.9MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 215304 | HENGRUI PHARMA |