SOFIE Application 203543

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMMONIA N 13	AMMONIA N-13	INJECTABLE;INTRAVENOUS	3.75-260mCi/ML	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47584-003	Ammonia	AMMONIA N-13	Houston Cyclotron Partners LP dba Cyclotope	ANDA	Current
49609-003	Ammonia	AMMONIA N-13	SOFIE Co. dba SOFIE	ANDA	Current