TARO PHARM INDS LTD FDA Approval ANDA 215674

ANDA 215674

TARO PHARM INDS LTD

FDA Drug Application

Application #215674

Application Sponsors

ANDA 215674TARO PHARM INDS LTD

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

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

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2022-04-14STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

TARO PHARM INDS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215674
            [companyName] => TARO PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"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"},{"drugName":"FLUPHENAZINE HYDROCHLORIDE","activeIngredients":"FLUPHENAZINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"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"},{"actionDate":"FLUPHENAZINE HYDROCHLORIDE","submission":"FLUPHENAZINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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