LANNETT CO INC FDA Approval ANDA 089743

ANDA 089743

LANNETT CO INC

FDA Drug Application

Application #089743

Application Sponsors

ANDA 089743LANNETT CO INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL10MG0FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE
002TABLET;ORAL1MG0FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE
003TABLET;ORAL2.5MG0FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE
004TABLET;ORAL5MG0FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1988-08-25
BIOEQUIV; BioequivalenceSUPPL8AP1992-11-10
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1993-11-26
LABELING; LabelingSUPPL11AP1993-08-27
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1994-08-31
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1997-07-09
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1997-11-26
MANUF (CMC); Manufacturing (CMC)SUPPL15AP1997-11-26
MANUF (CMC); Manufacturing (CMC)SUPPL16AP1998-01-16
MANUF (CMC); Manufacturing (CMC)SUPPL17AP1998-11-05
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2001-04-12
MANUF (CMC); Manufacturing (CMC)SUPPL19AP2001-08-16
LABELING; LabelingSUPPL21AP2008-07-25
LABELING; LabelingSUPPL22AP2009-01-23
LABELING; LabelingSUPPL23AP2010-03-12
LABELING; LabelingSUPPL25AP2010-12-03
LABELING; LabelingSUPPL28AP2017-02-23STANDARD

Submissions Property Types

SUPPL8Null0
SUPPL10Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL16Null0
SUPPL17Null0
SUPPL18Null0
SUPPL19Null0
SUPPL23Null7
SUPPL25Null7
SUPPL28Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

LANNETT CO INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89743
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUPHENAZINE HYDROCHLORIDE","activeIngredients":"FLUPHENAZINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"FLUPHENAZINE HYDROCHLORIDE","activeIngredients":"FLUPHENAZINE HYDROCHLORIDE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUPHENAZINE HYDROCHLORIDE","activeIngredients":"FLUPHENAZINE HYDROCHLORIDE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUPHENAZINE HYDROCHLORIDE","activeIngredients":"FLUPHENAZINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUPHENAZINE HYDROCHLORIDE","submission":"FLUPHENAZINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FLUPHENAZINE HYDROCHLORIDE","submission":"FLUPHENAZINE HYDROCHLORIDE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FLUPHENAZINE HYDROCHLORIDE","submission":"FLUPHENAZINE HYDROCHLORIDE","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FLUPHENAZINE HYDROCHLORIDE","submission":"FLUPHENAZINE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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