FDA.reportPublic FDA data

Application 214674

Type
ANDA
Sponsor
NOVITIUM PHARMA

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
10135-725FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDEMarlex Pharmaceuticals, Inc.ANDACurrent
10135-726FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDEMarlex Pharmaceuticals, Inc.ANDACurrent
10135-727FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDEMarlex Pharmaceuticals, Inc.ANDACurrent
10135-728FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDEMarlex Pharmaceuticals, Inc.ANDACurrent
70518-3095Fluphenazine HydrochlorideFluphenazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3098Fluphenazine HydrochlorideFluphenazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70954-273Fluphenazine HydrochlorideFluphenazine HydrochlorideNovitium Pharma LLCANDACurrent
70954-274Fluphenazine HydrochlorideFluphenazine HydrochlorideNovitium Pharma LLCANDACurrent
70954-275Fluphenazine HydrochlorideFluphenazine HydrochlorideNovitium Pharma LLCANDACurrent
70954-276Fluphenazine HydrochlorideFluphenazine HydrochlorideNovitium Pharma LLCANDACurrent