Application 215700

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE	NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE	INJECTABLE;INJECTION	4MG(16MCG PER ML)0.9%	No	No
002	NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE	NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE	INJECTABLE;INJECTION	8MG(32MCG PER ML)0.9%	No	No
003	NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE	NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE	INJECTABLE;INJECTION	16MG(64MCG PER ML)0.9%	No	No
004	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	NOREPINEPHRINE BITARTRATE	SOLUTION;INTRAVENOUS	EQ 32MG BASE/250ML (EQ 128MCG BASE/ML)	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
44567-640	NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	WG Critical Care, LLC	NDA	Current
44567-640	NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	WG Critical Care, LLC	NDA	Current
44567-640	NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	WG Critical Care, LLC	NDA	Current
44567-641	NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	WG Critical Care, LLC	NDA	Current
44567-641	NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	WG Critical Care, LLC	NDA	Current
44567-641	NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	WG Critical Care, LLC	NDA	Current
44567-642	NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	WG Critical Care, LLC	NDA	Current
44567-642	NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	WG Critical Care, LLC	NDA	Current
44567-642	NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	WG Critical Care, LLC	NDA	Current