FDA.reportPublic FDA data

Application 215141

Type
ANDA
Sponsor
ENALTEC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDETABLET;ORAL1MGNoNo
002FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDETABLET;ORAL2.5MGNoNo
003FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDETABLET;ORAL5MGNoNo
004FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62135-415fluphenazine hydrochloridefluphenazine hydrochlorideChartwell RX, LLCANDACurrent
62135-416fluphenazine hydrochloridefluphenazine hydrochlorideChartwell RX, LLCANDACurrent
62135-418fluphenazine hydrochloridefluphenazine hydrochlorideChartwell RX, LLCANDACurrent
62135-419fluphenazine hydrochloridefluphenazine hydrochlorideChartwell RX, LLCANDACurrent
90096-121Fluphenazine HydrochlorideFluphenazine HydrochlorideZameer Pharmaceuticals LLCANDACurrent
90096-122Fluphenazine HydrochlorideFluphenazine HydrochlorideZameer Pharmaceuticals LLCANDACurrent
90096-123Fluphenazine HydrochlorideFluphenazine HydrochlorideZameer Pharmaceuticals LLCANDACurrent
90096-124Fluphenazine HydrochlorideFluphenazine HydrochlorideZameer Pharmaceuticals LLCANDACurrent