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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208547
Company: AAA USA INC

Summary Review

Products on NDA 208547

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NETSPOT	GALLIUM DOTATATE GA-68	2.1-5.5mCi/ML	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208547

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/01/2016	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208547s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208547Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208547Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208547Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/26/2023	SUPPL-27	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208547s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208547Orig1s027ltr.pdf
12/22/2021	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208547s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208547Orig1s024ltr.pdf
06/22/2021	SUPPL-22	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208547s020s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208547Orig1s020, s022ltr.pdf
06/22/2021	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208547s020s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208547Orig1s020, s022ltr.pdf
08/09/2018	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
09/27/2018	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
04/12/2018	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208547s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208547Orig1s011ltr.pdf
01/20/2017	SUPPL-4	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208547s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208547Orig1s004ltr.pdf
10/31/2016	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/02/2016	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208547s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208547Orig1s002ltr.pdf

Labels for NDA 208547

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/26/2023	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208547s027lbl.pdf
10/26/2023	SUPPL-27	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208547s027lbl.pdf
12/22/2021	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208547s024lbl.pdf
06/22/2021	SUPPL-22	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208547s020s022lbl.pdf
06/22/2021	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208547s020s022lbl.pdf
04/12/2018	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208547s011lbl.pdf
01/20/2017	SUPPL-4	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208547s004lbl.pdf
09/02/2016	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208547s002lbl.pdf
06/01/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208547s000lbl.pdf

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