Application 208870

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DRAX EXAMETAZIME	TECHNETIUM TC-99M EXAMETAZIME KIT	POWDER;INTRAVENOUS	N/A	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65174-200	Drax Exametazime	Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling	Jubilant DraxImage Inc., dba Jubilant Radiopharma	NDA	Current
65174-200	Drax Exametazime	Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling	Jubilant DraxImage Inc.	NDA	Current
65174-200	Drax Exametazime	Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling	Jubilant DraxImage Inc., dba Jubilant Radiopharma	NDA	Current