FDA.reportPublic FDA data

Application 214552

Type
ANDA
Sponsor
ZYDUS

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
16714-672Fluphenazine HydrochlorideFluphenazine HydrochlorideNorthstar Rx LLCANDACurrent
16714-673Fluphenazine HydrochlorideFluphenazine HydrochlorideNorthstar Rx LLCANDACurrent
16714-674Fluphenazine HydrochlorideFluphenazine HydrochlorideNorthstar Rx LLCANDACurrent
16714-675Fluphenazine HydrochlorideFluphenazine HydrochlorideNorthstar Rx LLCANDACurrent
70710-1488Fluphenazine HydrochlorideFluphenazine HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1489Fluphenazine HydrochlorideFluphenazine HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1490Fluphenazine HydrochlorideFluphenazine HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1491Fluphenazine HydrochlorideFluphenazine HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1581Fluphenazine HydrochlorideFluphenazine HydrochlorideCadila Healthcare LimitedANDACurrent
70771-1582Fluphenazine HydrochlorideFluphenazine HydrochlorideCadila Healthcare LimitedANDACurrent
70771-1583Fluphenazine HydrochlorideFluphenazine HydrochlorideCadila Healthcare LimitedANDACurrent
70771-1584Fluphenazine HydrochlorideFluphenazine HydrochlorideCadila Healthcare LimitedANDACurrent