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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208700
Company: AAA USA INC

Products on NDA 208700

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LUTATHERA	LUTETIUM LU 177 DOTATATE	10mCi/ML	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208700

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/26/2018	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208700s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208700Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208700Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/23/2024	SUPPL-31	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208700s031lbl.pdf
03/07/2023	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208700s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208700Orig1s026ltr.pdf
06/13/2022	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208700s019s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208700s019s023lbl.pdf
06/06/2022	SUPPL-20	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208700Orig1s020ltr.pdf
06/13/2022	SUPPL-19	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208700s019s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208700Orig1s019,s023ltr.pdf
05/28/2020	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208700Orig1s010ltr.pdf
05/29/2020	SUPPL-1		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208700s010lbl.pdf

Labels for NDA 208700

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/23/2024	SUPPL-31	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208700s031lbl.pdf
03/07/2023	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208700s026lbl.pdf
06/13/2022	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208700s019s023lbl.pdf
06/13/2022	SUPPL-19	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208700s019s023lbl.pdf
05/29/2020	SUPPL-1	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208700s010lbl.pdf
01/26/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208700s000lbl.pdf

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