PAR PHARM FDA Approval ANDA 204521

ANDA 204521

PAR PHARM

FDA Drug Application

Application #204521

Application Sponsors

ANDA 204521PAR PHARM

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL1MG0PIMOZIDEPIMOZIDE
002TABLET;ORAL2MG0PIMOZIDEPIMOZIDE

FDA Submissions

UNKNOWN; ORIG1AP2015-09-28

Submissions Property Types

ORIG1Null7

CDER Filings

PAR PHARM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204521
            [companyName] => PAR PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIMOZIDE","activeIngredients":"PIMOZIDE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PIMOZIDE","activeIngredients":"PIMOZIDE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/28\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-09-28
        )

)

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