Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210016
Company: GE HEALTHCARE
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 |
|---|---|---|---|---|---|
| 12/15/2025 | SUPPL-22 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/15/2025 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2025 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2025 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/29/2023 | SUPPL-7 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 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 | 218073 | HAINAN POLY |
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 |
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 |
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 |
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 |