MICRO LABS FDA Approval ANDA 211711

ANDA 211711

MICRO LABS

FDA Drug Application

Application #211711

Application Sponsors

ANDA 211711MICRO LABS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL10MG0CLOBAZAMCLOBAZAM
002TABLET;ORAL20MG0CLOBAZAMCLOBAZAM

FDA Submissions

UNKNOWN; ORIG1AP2019-01-30STANDARD
LABELING; LabelingSUPPL3AP2021-11-12STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

MICRO LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211711
            [companyName] => MICRO LABS
            [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":"01\/30\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-30
        )

)

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