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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204677
Company: LANTHEUS

Summary Review

Products on NDA 204677

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NEURACEQ	FLORBETABEN F-18	1.4-135mCi/ML	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204677

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/19/2014	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204677s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204677Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204677Orig1s000TOC.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204677Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/23/2025	SUPPL-34	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204677s024s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204677Orig1s024,s034ltr.pdf
06/23/2025	SUPPL-24	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204677s024s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204677Orig1s024,s034ltr.pdf
10/31/2023	SUPPL-23	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204677Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204677Orig1s023ltr.pdf
06/08/2022	SUPPL-21	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204677Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204677Orig1s021ltr.pdf
01/10/2020	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204677s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204677Orig1s019ltr.pdf
07/10/2018	SUPPL-15	Labeling-Container/Carton Labels		Label is not available on this site.
06/16/2017	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204677s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204677Orig1s014ltr.pdf
03/08/2016	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
08/25/2016	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204677s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204677Orig1s012ltr.pdf
10/03/2016	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204677s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204677Orig1s011ltr.pdf
01/25/2016	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
05/18/2015	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
05/19/2015	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/04/2015	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
08/13/2014	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/15/2014	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
10/15/2014	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/04/2014	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204677s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204677Orig1s001ltr.pdf

Labels for NDA 204677

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/23/2025	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204677s024s034lbl.pdf
06/23/2025	SUPPL-24	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204677s024s034lbl.pdf
10/31/2023	SUPPL-23	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204677Orig1s023lbl.pdf
06/08/2022	SUPPL-21	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204677Orig1s021lbl.pdf
01/10/2020	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204677s019lbl.pdf
06/16/2017	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204677s014lbl.pdf
10/03/2016	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204677s011lbl.pdf
08/25/2016	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204677s012lbl.pdf
04/04/2014	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204677s001lbl.pdf
03/19/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204677s000lbl.pdf

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