BRISTOL MYERS SQUIBB FDA Approval NDA 009357

NDA 009357

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #009357

Application Sponsors

NDA 009357BRISTOL MYERS SQUIBB

Marketing Status

Discontinued001
Discontinued004
Discontinued006
Discontinued008

Application Products

001TABLET;ORAL0.1MG0RAU-SEDRESERPINE
004TABLET;ORAL0.25MG0RAU-SEDRESERPINE
006TABLET;ORAL0.5MG0RAU-SEDRESERPINE
008TABLET;ORAL1MG0RAU-SEDRESERPINE

CDER Filings

BRISTOL MYERS SQUIBB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 9357
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"RAU-SED","activeIngredients":"RESERPINE","strength":"0.1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RAU-SED","activeIngredients":"RESERPINE","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RAU-SED","activeIngredients":"RESERPINE","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RAU-SED","activeIngredients":"RESERPINE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RAU-SED","submission":"RESERPINE","actionType":"0.1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RAU-SED","submission":"RESERPINE","actionType":"0.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RAU-SED","submission":"RESERPINE","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RAU-SED","submission":"RESERPINE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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