Application 215821

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 5GM BASE/VIAL	No	No
002	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 10GM BASE/VIAL	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70436-022	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-023	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Slate Run Pharmaceuticals, LLC	ANDA	Current