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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203137
Company: GE HEALTHCARE

Products on NDA 203137

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VIZAMYL	FLUTEMETAMOL F-18	40.5mCi/10ML (4.05mCi/ML)	INJECTABLE;INTRAVENOUS	Discontinued	None	Yes	No
VIZAMYL	FLUTEMETAMOL F-18	121.5mCi/30ML (4.05mCi/ML)	INJECTABLE;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203137

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/25/2013	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203137s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203137Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203137_vizamyl_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/10/2020	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203137s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203137Orig1s013ltr.pdf
02/22/2017	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203137s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203137Orig1s008ltr.pdf
11/21/2016	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
04/07/2016	SUPPL-5	Labeling, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203137s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203137Orig1s005ltr.pdf
06/07/2016	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
12/04/2014	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203137s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203137Orig1s002ltr.pdf
02/03/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 203137

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/10/2020	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203137s013lbl.pdf
02/22/2017	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203137s008lbl.pdf
04/07/2016	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203137s005lbl.pdf
04/07/2016	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203137s005lbl.pdf
12/04/2014	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203137s002lbl.pdf
10/25/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203137s000lbl.pdf

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