PAR PHARM FDA Approval ANDA 202540

ANDA 202540

PAR PHARM

FDA Drug Application

Application #202540

Application Sponsors

ANDA 202540PAR PHARM

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL250MG0URSODIOLURSODIOL
002TABLET;ORAL500MG0URSODIOLURSODIOL

FDA Submissions

UNKNOWN; ORIG1AP2013-02-14

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

PAR PHARM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202540
            [companyName] => PAR PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"URSODIOL","activeIngredients":"URSODIOL","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"URSODIOL","activeIngredients":"URSODIOL","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/14\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/29\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-05-29
        )

)

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