ANI PHARMS INC FDA Approval ANDA 085370

ANDA 085370

ANI PHARMS INC

FDA Drug Application

Application #085370

Application Sponsors

ANDA 085370ANI PHARMS INC

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL5MG0DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE

CDER Filings

ANI PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85370
            [companyName] => ANI PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROAMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXTROAMPHETAMINE SULFATE","submission":"DEXTROAMPHETAMINE SULFATE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.