Application 216961

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	THEOPHYLLINE	THEOPHYLLINE	TABLET, EXTENDED RELEASE;ORAL	300MG	No	No
002	THEOPHYLLINE	THEOPHYLLINE	TABLET, EXTENDED RELEASE;ORAL	450MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0480-3309	Theophylline	Theophylline	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-3310	Theophylline	Theophylline	Teva Pharmaceuticals, Inc.	ANDA	Current