Drugs@FDA: FDA-Approved Drugs

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

• Summary Review

Products on NDA 019785

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019785

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/21/1990	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

Supplements

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) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019785s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019785Orig1s022ltr.pdf
04/30/2008	SUPPL-18	Efficacy-New Patient Population	Label (PDF) Letter (PDF) Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019785s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019785s018ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/019785se5-018_SumR.pdf
06/08/2000	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
02/11/2000	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
01/14/2000	SUPPL-13	Labeling		Label is not available on this site.
01/22/2002	SUPPL-12	Labeling		Label is not available on this site.
06/10/1998	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
08/08/1997	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
04/24/1997	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
09/26/1996	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
11/08/1996	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
05/23/1997	SUPPL-6	Efficacy-New Patient Population		Label is not available on this site.
12/14/1995	SUPPL-5	Efficacy-New Patient Population		Label is not available on this site.
12/14/1995	SUPPL-4	Efficacy-New Indication		Label is not available on this site.
02/28/1996	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
09/09/1992	SUPPL-2	Efficacy-New Indication		Label is not available on this site.
01/30/1992	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

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

Therapeutic Equivalents for NDA 019785

CARDIOLITE

INJECTABLE;INJECTION; N/A
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARDIOLITE	TECHNETIUM TC-99M SESTAMIBI KIT	N/A	INJECTABLE;INJECTION	Prescription	Yes	AP	019785	LANTHEUS MEDCL
TECHNETIUM TC 99M SESTAMIBI	TECHNETIUM TC-99M SESTAMIBI KIT	N/A	INJECTABLE;INJECTION	Prescription	No	AP	078809	CARDINAL HEALTH 414
TECHNETIUM TC 99M SESTAMIBI	TECHNETIUM TC-99M SESTAMIBI KIT	N/A	INJECTABLE;INJECTION	Prescription	No	AP	078098	CURIUM
TECHNETIUM TC 99M SESTAMIBI	TECHNETIUM TC-99M SESTAMIBI KIT	N/A	INJECTABLE;INJECTION	Prescription	No	AP	078806	JUBILANT DRAXIMAGE

MIRALUMA

There are no Therapeutic Equivalents.