ACCORD HLTHCARE FDA Approval ANDA 212398

ANDA 212398

ACCORD HLTHCARE

FDA Drug Application

Application #212398

Application Sponsors

ANDA 212398ACCORD HLTHCARE

Marketing Status

Discontinued001
Discontinued002

Application Products

001TABLET;ORAL10MG0CLOBAZAMCLOBAZAM
002TABLET;ORAL20MG0CLOBAZAMCLOBAZAM

FDA Submissions

UNKNOWN; ORIG1AP2019-05-23STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

ACCORD HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212398
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOBAZAM","activeIngredients":"CLOBAZAM","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLOBAZAM","activeIngredients":"CLOBAZAM","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/23\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-05-23
        )

)

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