Application 204465

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMMONIA N 13	AMMONIA N-13	INJECTABLE;INTRAVENOUS	30mCi-300mCi/8ML (3.75-37.5mCi/ML)	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69126-001	Ammonia N 13	Ammonia N 13	Global Isotopes, LLC d/b/a Zevacor Molecular	ANDA	Current
73410-001	Ammonia N 13	Ammonia N 13	Decatur Memorial Hospital	ANDA	Current