Application 019785

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARDIOLITE	TECHNETIUM TC-99M SESTAMIBI KIT	INJECTABLE;INJECTION	N/A	Yes	Yes
003	MIRALUMA	TECHNETIUM TC-99M SESTAMIBI KIT	INJECTABLE;INJECTION	N/A	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11994-001	Cardiolite	TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE	Lantheus Medical Imaging, Inc.	NDA	Current
11994-001	Cardiolite	TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE	Lantheus Medical Imaging, Inc.	NDA	Current
11994-001	Cardiolite	TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE	Lantheus Medical Imaging, Inc.	NDA	Current
11994-003	Kit for the Preparation of Technetium Tc99m Sestamibi	TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE	Lantheus Medical Imaging, Inc.	NDA	Current
11994-003	Kit for the Preparation of Technetium Tc99m Sestamibi	TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE	Lantheus Medical Imaging, Inc.	NDA	Current
11994-003	Kit for the Preparation of Technetium Tc99m Sestamibi	TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE	Lantheus Medical Imaging, Inc.	NDA	Current