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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208054
Company: BLUE EARTH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AXUMIN FLUCICLOVINE F-18 9-221mCi/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
05/27/2016 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/2016/208054s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208054Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208054Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208054Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/21/2021 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208054s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208054Orig1s034ltr.pdf
01/24/2017 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/19/2016 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/21/2021 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208054s034lbl.pdf
05/27/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208054s000lbl.pdf
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