BIONPHARMA INC FDA Approval ANDA 208825

ANDA 208825

BIONPHARMA INC

FDA Drug Application

Application #208825

Application Sponsors

ANDA 208825BIONPHARMA INC

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL10MG0CLOBAZAMCLOBAZAM
002TABLET;ORAL20MG0CLOBAZAMCLOBAZAM

FDA Submissions

UNKNOWN; ORIG1AP2018-10-22STANDARD
LABELING; LabelingSUPPL2AP2021-11-08STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

BIONPHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208825
            [companyName] => BIONPHARMA INC
            [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":"10\/22\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-22
        )

)

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