Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208054
Company: BLUE EARTH

• Summary Review

Products on NDA 208054

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208054

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.

Labels for NDA 208054

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