FDA.reportPublic FDA data

Application 213647

Type
ANDA
Sponsor
AMNEAL

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
16714-002fluphenazine hydrochloridefluphenazine hydrochlorideNorthStar Rx LLCANDACurrent
16714-002fluphenazine hydrochloridefluphenazine hydrochlorideNorthStar Rx LLCANDACurrent
16714-003fluphenazine hydrochloridefluphenazine hydrochlorideNorthStar Rx LLCANDACurrent
16714-003fluphenazine hydrochloridefluphenazine hydrochlorideNorthStar Rx LLCANDACurrent
16714-004fluphenazine hydrochloridefluphenazine hydrochlorideNorthStar Rx LLCANDACurrent
16714-004fluphenazine hydrochloridefluphenazine hydrochlorideNorthStar Rx LLCANDACurrent
16714-005fluphenazine hydrochloridefluphenazine hydrochlorideNorthStar Rx LLCANDACurrent
16714-005fluphenazine hydrochloridefluphenazine hydrochlorideNorthStar Rx LLCANDACurrent
60219-1678fluphenazine hydrochloridefluphenazine hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
60219-1678fluphenazine hydrochloridefluphenazine hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
60219-1678fluphenazine hydrochloridefluphenazine hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
60219-1679fluphenazine hydrochloridefluphenazine hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
60219-1679fluphenazine hydrochloridefluphenazine hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
60219-1679fluphenazine hydrochloridefluphenazine hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
60219-1680fluphenazine hydrochloridefluphenazine hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
60219-1680fluphenazine hydrochloridefluphenazine hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
60219-1680fluphenazine hydrochloridefluphenazine hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
60219-1681fluphenazine hydrochloridefluphenazine hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
60219-1681fluphenazine hydrochloridefluphenazine hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
60219-1681fluphenazine hydrochloridefluphenazine hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1678fluphenazine hydrochloridefluphenazine hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1678fluphenazine hydrochloridefluphenazine hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1679fluphenazine hydrochloridefluphenazine hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1679fluphenazine hydrochloridefluphenazine hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1680fluphenazine hydrochloridefluphenazine hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1680fluphenazine hydrochloridefluphenazine hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1681fluphenazine hydrochloridefluphenazine hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1681fluphenazine hydrochloridefluphenazine hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
70518-3003fluphenazine hydrochloridefluphenazine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3008fluphenazine hydrochloridefluphenazine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3569fluphenazine hydrochloridefluphenazine hydrochlorideREMEDYREPACK INC.ANDACurrent