IMPAX LABS FDA Approval ANDA 083720

ANDA 083720

IMPAX LABS

FDA Drug Application

Application #083720

Application Sponsors

ANDA 083720IMPAX LABS

Marketing Status

Discontinued002

Application Products

002TABLET;ORAL0.5MG;500MG0PROBENECID AND COLCHICINECOLCHICINE; PROBENECID

CDER Filings

IMPAX LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83720
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROBENECID AND COLCHICINE","activeIngredients":"COLCHICINE; PROBENECID","strength":"0.5MG;500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROBENECID AND COLCHICINE","submission":"COLCHICINE; PROBENECID","actionType":"0.5MG;500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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