JUBILANT DRAXIMAGE Application 018035

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DRAXIMAGE MDP-10	TECHNETIUM TC-99M MEDRONATE	INJECTABLE;INJECTION	N/A	No	No
002	DRAXIMAGE MDP-25	TECHNETIUM TC-99M MEDRONATE	INJECTABLE;INJECTION	N/A	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65174-660	Technetium Tc 99m Medronate	Technetium Tc 99m Medronate	Jubilant DraxImage Inc., dba Jubilant Radiopharma	NDA	Current
65174-660	Technetium Tc 99m Medronate	Technetium Tc 99m Medronate	Jubilant DraxImage Inc	NDA	Current