Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019785
Company: LANTHEUS MEDCL

• Summary Review

Products on NDA 19785

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARDIOLITE	TECHNETIUM TC-99M SESTAMIBI KIT	N/A	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
MIRALUMA	TECHNETIUM TC-99M SESTAMIBI KIT	N/A	INJECTABLE;INJECTION	Discontinued	None	No	No

Labels for NDA 019785

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/04/2019	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019785s022lbl.pdf
04/30/2008	SUPPL-18	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019785s018lbl.pdf