Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204781
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 None Yes Yes
DOTAREM GADOTERATE MEGLUMINE 3.769GM/10ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
DOTAREM GADOTERATE MEGLUMINE 5.6535GM/15ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
DOTAREM GADOTERATE MEGLUMINE 7.538GM/20ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
DOTAREM GADOTERATE MEGLUMINE 1.8845GM/5ML (376.9MG/ML) SOLUTION;INTRAVENOUS Prescription None 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
07/23/2019 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-Medication Guide, Labeling-Package Insert 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
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-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204781s008lbl.pdf
04/26/2018 SUPPL-8 Labeling-Package Insert 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

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