FDA.reportPublic FDA data

Application 091176

Type
ANDA
Sponsor
MYLAN

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
0378-2586Hydroxyzine Hydrochloridehydroxyzine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2587Hydroxyzine Hydrochloridehydroxyzine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2588Hydroxyzine Hydrochloridehydroxyzine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
51079-796Hydroxyzine Hydrochloridehydroxyzine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-816Hydroxyzine Hydrochloridehydroxyzine hydrochlorideMylan Institutional Inc.ANDACurrent
55154-5377Hydroxyzine Hydrochloridehydroxyzine hydrochlorideCardinal HealthANDACurrent
63629-6518Hydroxyzine Hydrochloridehydroxyzine hydrochlorideBryant Ranch PrepackANDACurrent