BRISTOL MYERS SQUIBB FDA Approval NDA 011359

NDA 011359

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #011359

Application Sponsors

NDA 011359BRISTOL MYERS SQUIBB

Marketing Status

Discontinued001
Discontinued002

Application Products

001TABLET;ORAL2MG0ORA-TESTRYLFLUOXYMESTERONE
002TABLET;ORAL5MG0ORA-TESTRYLFLUOXYMESTERONE

CDER Filings

BRISTOL MYERS SQUIBB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 11359
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"ORA-TESTRYL","activeIngredients":"FLUOXYMESTERONE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ORA-TESTRYL","activeIngredients":"FLUOXYMESTERONE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ORA-TESTRYL","submission":"FLUOXYMESTERONE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ORA-TESTRYL","submission":"FLUOXYMESTERONE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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