APPCO FDA Approval ANDA 210163

ANDA 210163

APPCO

FDA Drug Application

Application #210163

Application Sponsors

ANDA 210163APPCO

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL2MG0PERPHENAZINEPERPHENAZINE
002TABLET;ORAL4MG0PERPHENAZINEPERPHENAZINE
003TABLET;ORAL8MG0PERPHENAZINEPERPHENAZINE
004TABLET;ORAL16MG0PERPHENAZINEPERPHENAZINE

FDA Submissions

UNKNOWN; ORIG1AP2022-05-18STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

APPCO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210163
            [companyName] => APPCO
            [docInserts] => ["",""]
            [products] => [{"drugName":"PERPHENAZINE","activeIngredients":"PERPHENAZINE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PERPHENAZINE","activeIngredients":"PERPHENAZINE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PERPHENAZINE","activeIngredients":"PERPHENAZINE","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PERPHENAZINE","activeIngredients":"PERPHENAZINE","strength":"16MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/18\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-18
        )

)

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