Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 204781
Company: GUERBET
Company: GUERBET
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOTAREM | GADOTERATE MEGLUMINE | 37.69GM/100ML (376.9MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | Yes | Yes |
| DOTAREM | GADOTERATE MEGLUMINE | 3.769GM/10ML (376.9MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | Yes | Yes |
| DOTAREM | GADOTERATE MEGLUMINE | 5.6535GM/15ML (376.9MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | Yes | Yes |
| DOTAREM | GADOTERATE MEGLUMINE | 7.538GM/20ML (376.9MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | Yes | Yes |
| DOTAREM | GADOTERATE MEGLUMINE | 1.8845GM/5ML (376.9MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/20/2013 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204781s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204781Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204781Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204781Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/23/2024 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204781s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204781Orig1s016ltr.pdf | |
| 01/26/2024 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204781s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204781Orig1s015ltr.pdf | |
| 08/14/2024 | SUPPL-14 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204781Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204781Orig1s014ltr.pdf | |
| 07/23/2019 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204781s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204781Orig1s012ltr.pdf | |
| 11/02/2018 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204781s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204781Orig1s009ltr.pdf | |
| 04/26/2018 | SUPPL-8 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204781s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204781Orig1s008Ltr.pdf | |
| 09/14/2017 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204781s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204781Orig1s005ltr.pdf | |
| 03/31/2017 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/25/2017 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204781s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204781Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/14/2024 | SUPPL-14 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204781Orig1s014lbl.pdf | |
| 07/23/2024 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204781s016lbl.pdf | |
| 01/26/2024 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204781s015lbl.pdf | |
| 07/23/2019 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204781s012lbl.pdf | |
| 11/02/2018 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204781s009lbl.pdf | |
| 04/26/2018 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204781s008lbl.pdf | |
| 04/26/2018 | SUPPL-8 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204781s008lbl.pdf | |
| 09/14/2017 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204781s005lbl.pdf | |
| 08/25/2017 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204781s001lbl.pdf | |
| 03/20/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204781s000lbl.pdf |
DOTAREM
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 |
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; 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 |