Application 019826

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	INJECTABLE;INJECTION	40MG/100ML	Yes	Yes
002	THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	INJECTABLE;INJECTION	80MG/100ML	Yes	Yes
003	THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	INJECTABLE;INJECTION	160MG/100ML	Yes	Yes
004	THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	INJECTABLE;INJECTION	200MG/100ML	No	No
005	THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	INJECTABLE;INJECTION	400MG/100ML	No	No
006	THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	INJECTABLE;INJECTION	320MG/100ML	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0264-9554	Theophylline in Dextrose	Theophylline Anhydrous and Dextrose	B. Braun Medical Inc.	NDA	Current