APOTEX FDA Approval ANDA 216649

ANDA 216649

APOTEX

FDA Drug Application

Application #216649

Application Sponsors

ANDA 216649APOTEX

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

UNKNOWN; ORIG1AP2022-07-15STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

APOTEX
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216649
            [companyName] => APOTEX
            [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":"07\/15\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-15
        )

)

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