MIKART FDA Approval ANDA 207483

ANDA 207483

MIKART

FDA Drug Application

Application #207483

Application Sponsors

ANDA 207483MIKART

Marketing Status

Prescription001

Application Products

001TABLET;ORAL250MG0CHLORZOXAZONECHLORZOXAZONE

FDA Submissions

UNKNOWN; ORIG1AP2016-06-24STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA

CDER Filings

MIKART
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207483
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORZOXAZONE","activeIngredients":"CHLORZOXAZONE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/24\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-06-24
        )

)

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