TWI PHARMS FDA Approval ANDA 215848

ANDA 215848

TWI PHARMS

FDA Drug Application

Application #215848

Application Sponsors

ANDA 215848TWI PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2022-04-01STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

TWI PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215848
            [companyName] => TWI PHARMS
            [docInserts] => ["",""]
            [products] => [{"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":"04\/01\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-01
        )

)

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