FDA.reportPublic FDA data

Application 089804

Type
ANDA
Sponsor
MYLAN

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-6004Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6004Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6009Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6009Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6074Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6074Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6097Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6097Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0615-1501Fluphenazine HydrochlorideFluphenazine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-3574Fluphenazine HydrochlorideFluphenazine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
51079-485Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-485Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-485Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-486Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-486Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-486Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-487Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-487Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-487Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-488Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-488Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-488Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Institutional Inc.ANDACurrent
53808-0247Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEState of Florida DOH Central PharmacyANDACurrent
53808-0600Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEState of Florida DOH Central PharmacyANDACurrent
70518-0457Fluphenazine hydrochlorideFluphenazine hydrochlorideREMEDYREPACK INC.ANDACurrent