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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021064
Company: LANTHEUS MEDCL

Summary Review

Other Important Information from FDA

Products on NDA 021064

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEFINITY	PERFLUTREN	13.04MG/2ML (6.52MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	None	Yes	Yes
DEFINITY RT	PERFLUTREN	13.04MG/2ML (6.52MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021064

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/31/2001	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-064_Definity_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-064_Definity_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-064_Definity.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/01/2024	SUPPL-33	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021064s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021064Orig1s033ltr.pdf
06/05/2023	SUPPL-32	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021064s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021064Orig1s032ltr.pdf
04/09/2021	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021064s025s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021064Orig1s025, s029ltr.pdf
04/09/2021	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021064s025s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021064Orig1s025,%20s029ltr.pdf
11/17/2020	SUPPL-24	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021064s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021064Orig1s024ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/021064Orig1s024.pdf
07/30/2020	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021064s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021064Orig1s023ltr.pdf
12/12/2018	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021064s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021064Orig1s022ltr.pdf
04/13/2018	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
01/19/2017	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021064s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021064Orig1s020ltr.pdf
11/23/2015	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
08/18/2015	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021064s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021064Orig1s017ltr.pdf
02/05/2013	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
10/24/2011	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021064s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021064s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021064Orig1s011TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021064Orig1s011SumR.pdf
05/12/2008	SUPPL-9	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021064s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021064s009ltr.pdf
10/10/2007	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021064s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021064s007ltr.pdf
05/06/2005	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021064s006lbl.pdf
01/30/2003	SUPPL-4	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21064scm004ltr.pdf
07/08/2002	SUPPL-2	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21064slr002ltr.pdf
02/21/2002	SUPPL-1	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21064s1ltr.pdf

Labels for NDA 021064

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/01/2024	SUPPL-33	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021064s033lbl.pdf
06/05/2023	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021064s032lbl.pdf
04/09/2021	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021064s025s029lbl.pdf
04/09/2021	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021064s025s029lbl.pdf
11/17/2020	SUPPL-24	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021064s024lbl.pdf
07/30/2020	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021064s023lbl.pdf
12/12/2018	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021064s022lbl.pdf
01/19/2017	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021064s020lbl.pdf
08/18/2015	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021064s017lbl.pdf
10/24/2011	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021064s011lbl.pdf
05/12/2008	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021064s009lbl.pdf
10/10/2007	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021064s007lbl.pdf
05/06/2005	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021064s006lbl.pdf
07/31/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-064_Definity_prntlbl.pdf

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