FDA.reportPublic FDA data

Application 040812

Type
ANDA
Sponsor
INVAGEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDETABLET;ORAL10MGNoNo
002HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDETABLET;ORAL25MGNoNo
003HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDETABLET;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-2650hydroxyzine hydrochloridehydroxyzine hydrochlorideA-S Medication SolutionsANDACurrent
50090-2930hydroxyzine hydrochloridehydroxyzine hydrochlorideA-S Medication SolutionsANDACurrent
53808-0632Hydroxyzine HydrochlorideHydroxyzine HydrochlorideState of Florida DOH Central PharmacyANDACurrent
68462-352hydroxyzine hydrochloridehydroxyzine hydrochlorideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-353hydroxyzine hydrochloridehydroxyzine hydrochlorideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-354hydroxyzine hydrochloridehydroxyzine hydrochlorideGlenmark Pharmaceuticals Inc., USAANDACurrent