Application 021064

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEFINITY	PERFLUTREN	INJECTABLE;INTRAVENOUS	6.52MG/ML	Yes	Yes
002	DEFINITY RT	PERFLUTREN	INJECTABLE;INTRAVENOUS	6.52MG/ML	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11994-011	Definity	perflutren	Lantheus Medical Imaging, Inc.	NDA	Current
11994-011	Definity	perflutren	Lantheus Medical Imaging, Inc.	NDA	Current
11994-011	Definity	perflutren	Lantheus Medical Imaging, Inc.	NDA	Current
11994-011	Definity	perflutren	Lantheus Medical Imaging, Inc.	NDA	Current
11994-011	Definity	perflutren	Lantheus Medical Imaging, Inc.	NDA	Current
11994-017	DEFINITY RT	perflutren	Lantheus Medical Imaging, Inc.	NDA	Current
11994-017	DEFINITY RT	perflutren	Lantheus Medical Imaging, Inc.	NDA	Current
11994-017	DEFINITY RT	perflutren	Lantheus Medical Imaging, Inc.	NDA	Current