APPCO Application 207367

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUDESONIDE	BUDESONIDE	CAPSULE;ORAL	3MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60687-421	Budesonide	budesonide	American Health Packaging	ANDA	Current
60687-421	Budesonide	budesonide	American Health Packaging	ANDA	Current
64980-255	Budesonide	budesonide	Rising Pharmaceuticals, Inc.	ANDA	Current