APOTEX FDA Approval ANDA 209853

ANDA 209853

APOTEX

FDA Drug Application

Application #209853

Application Sponsors

ANDA 209853APOTEX

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL10MG0CLOBAZAMCLOBAZAM
002TABLET;ORAL20MG0CLOBAZAMCLOBAZAM

FDA Submissions

UNKNOWN; ORIG1AP2020-06-09STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

APOTEX
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209853
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOBAZAM","activeIngredients":"CLOBAZAM","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLOBAZAM","activeIngredients":"CLOBAZAM","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/09\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-09
        )

)

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