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 21064

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

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