STRIDES PHARMA FDA Approval ANDA 213504

ANDA 213504

STRIDES PHARMA

FDA Drug Application

Application #213504

Application Sponsors

ANDA 213504STRIDES PHARMA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL250MG0URSODIOLURSODIOL
002TABLET;ORAL500MG0URSODIOLURSODIOL

FDA Submissions

UNKNOWN; ORIG1AP2020-08-20STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

STRIDES PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213504
            [companyName] => STRIDES PHARMA
            [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":"08\/20\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-20
        )

)

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