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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208700
Company: AAA USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LUTATHERA LUTETIUM LU 177 DOTATATE 10mCi/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
01/26/2018 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208700s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208700Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208700Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/13/2022 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208700s019s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208700s019s023lbl.pdf
06/06/2022 SUPPL-20 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208700Orig1s020ltr.pdf
06/13/2022 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208700s019s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208700Orig1s019,s023ltr.pdf
05/28/2020 SUPPL-10 Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208700Orig1s010ltr.pdf
05/29/2020 SUPPL-1 Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208700s010lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/13/2022 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208700s019s023lbl.pdf
06/13/2022 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208700s019s023lbl.pdf
05/29/2020 SUPPL-1 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208700s010lbl.pdf
01/26/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208700s000lbl.pdf
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