FDA.reportPublic FDA data

Application 215848

Type
ANDA
Sponsor
TWI PHARMS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24979-136Fluphenazine HydrochlorideFluphenazine HydrochlorideTWi Pharmaceuticals, Inc.ANDACurrent
24979-137Fluphenazine HydrochlorideFluphenazine HydrochlorideTWi Pharmaceuticals, Inc.ANDACurrent
24979-137Fluphenazine HydrochlorideFluphenazine HydrochlorideTWi Pharmaceuticals, Inc.ANDACurrent
24979-138Fluphenazine HydrochlorideFluphenazine HydrochlorideTWi Pharmaceuticals, Inc.ANDACurrent
24979-138Fluphenazine HydrochlorideFluphenazine HydrochlorideTWi Pharmaceuticals, Inc.ANDACurrent
24979-139Fluphenazine HydrochlorideFluphenazine HydrochlorideTWi Pharmaceuticals, Inc.ANDACurrent
24979-139Fluphenazine HydrochlorideFluphenazine HydrochlorideTWi Pharmaceuticals, Inc.ANDACurrent