ANIMA Application 086880

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	SYRUP;ORAL	10MG/5ML	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
54879-006	Hydroxyzine HCl	Hydroxyzine HCl	STI Pharma LLC	ANDA	Current
54879-006	Hydroxyzine HCl	Hydroxyzine HCl	STI Pharma LLC	ANDA	Current