TARO FDA Approval ANDA 209440

ANDA 209440

TARO

FDA Drug Application

Application #209440

Application Sponsors

ANDA 209440TARO

Marketing Status

Discontinued001
Discontinued002

Application Products

001TABLET;ORAL10MG0CLOBAZAMCLOBAZAM
002TABLET;ORAL20MG0CLOBAZAMCLOBAZAM

FDA Submissions

UNKNOWN; ORIG1AP2018-10-22STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

TARO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209440
            [companyName] => TARO
            [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":"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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