NEXGEN PHARMA INC FDA Approval ANDA 085985

ANDA 085985

NEXGEN PHARMA INC

FDA Drug Application

Application #085985

Application Sponsors

ANDA 085985NEXGEN PHARMA INC

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL50MG0DIMENHYDRINATEDIMENHYDRINATE

FDA Submissions

ORIG1AP1977-12-19

CDER Filings

NEXGEN PHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85985
            [companyName] => NEXGEN PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIMENHYDRINATE","activeIngredients":"DIMENHYDRINATE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DIMENHYDRINATE","submission":"DIMENHYDRINATE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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