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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213227
Company: RADIOMEDIX

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DETECTNET COPPER CU-64 DOTATATE 4mL (1mCi/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
09/03/2020 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213227s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213227Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213227Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/22/2021 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213227s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213227Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/22/2021 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213227s001lbl.pdf
09/03/2020 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213227s000lbl.pdf
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