BRISTOL MYERS SQUIBB FDA Approval NDA 004056

NDA 004056

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #004056

Application Sponsors

NDA 004056BRISTOL MYERS SQUIBB

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004
Discontinued005
Discontinued006
Discontinued007
Discontinued008
Discontinued009
Discontinued010
Discontinued011
Discontinued012
Discontinued013
Discontinued014
Discontinued017

Application Products

001SUPPOSITORY;VAGINAL0.1MG0STILBESTROLDIETHYLSTILBESTROL
002SUPPOSITORY;VAGINAL0.5MG0STILBESTROLDIETHYLSTILBESTROL
003INJECTABLE;INJECTION0.2MG/ML0STILBESTROLDIETHYLSTILBESTROL
004INJECTABLE;INJECTION0.5MG/ML0STILBESTROLDIETHYLSTILBESTROL
005INJECTABLE;INJECTION1MG/ML0STILBESTROLDIETHYLSTILBESTROL
006INJECTABLE;INJECTION5MG/ML0STILBESTROLDIETHYLSTILBESTROL
007TABLET;ORAL0.1MG0STILBETINDIETHYLSTILBESTROL
008TABLET;ORAL0.5MG0STILBETINDIETHYLSTILBESTROL
009TABLET;ORAL1MG0STILBETINDIETHYLSTILBESTROL
010TABLET;ORAL5MG0STILBETINDIETHYLSTILBESTROL
011TABLET, DELAYED RELEASE;ORAL0.1MG0STILBETINDIETHYLSTILBESTROL
012TABLET, DELAYED RELEASE;ORAL0.5MG0STILBETINDIETHYLSTILBESTROL
013TABLET, DELAYED RELEASE;ORAL1MG0STILBETINDIETHYLSTILBESTROL
014TABLET, DELAYED RELEASE;ORAL5MG0STILBETINDIETHYLSTILBESTROL
017TABLET;ORAL0.25MG0STILBETINDIETHYLSTILBESTROL

CDER Filings

BRISTOL MYERS SQUIBB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 4056
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"STILBESTROL","activeIngredients":"DIETHYLSTILBESTROL","strength":"0.1MG","dosageForm":"SUPPOSITORY;VAGINAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"STILBESTROL","activeIngredients":"DIETHYLSTILBESTROL","strength":"0.5MG","dosageForm":"SUPPOSITORY;VAGINAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"STILBESTROL","activeIngredients":"DIETHYLSTILBESTROL","strength":"0.2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"STILBESTROL","activeIngredients":"DIETHYLSTILBESTROL","strength":"0.5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"STILBESTROL","activeIngredients":"DIETHYLSTILBESTROL","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"STILBESTROL","activeIngredients":"DIETHYLSTILBESTROL","strength":"5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"STILBETIN","activeIngredients":"DIETHYLSTILBESTROL","strength":"0.1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"STILBETIN","activeIngredients":"DIETHYLSTILBESTROL","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"STILBETIN","activeIngredients":"DIETHYLSTILBESTROL","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"STILBETIN","activeIngredients":"DIETHYLSTILBESTROL","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"STILBETIN","activeIngredients":"DIETHYLSTILBESTROL","strength":"0.1MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"STILBETIN","activeIngredients":"DIETHYLSTILBESTROL","strength":"0.5MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"STILBETIN","activeIngredients":"DIETHYLSTILBESTROL","strength":"1MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"STILBETIN","activeIngredients":"DIETHYLSTILBESTROL","strength":"5MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"STILBETIN","activeIngredients":"DIETHYLSTILBESTROL","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"STILBESTROL","submission":"DIETHYLSTILBESTROL","actionType":"0.1MG","submissionClassification":"SUPPOSITORY;VAGINAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"STILBESTROL","submission":"DIETHYLSTILBESTROL","actionType":"0.5MG","submissionClassification":"SUPPOSITORY;VAGINAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"STILBESTROL","submission":"DIETHYLSTILBESTROL","actionType":"0.2MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"STILBESTROL","submission":"DIETHYLSTILBESTROL","actionType":"0.5MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"STILBESTROL","submission":"DIETHYLSTILBESTROL","actionType":"1MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"STILBESTROL","submission":"DIETHYLSTILBESTROL","actionType":"5MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"STILBETIN","submission":"DIETHYLSTILBESTROL","actionType":"0.1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"STILBETIN","submission":"DIETHYLSTILBESTROL","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"STILBETIN","submission":"DIETHYLSTILBESTROL","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"STILBETIN","submission":"DIETHYLSTILBESTROL","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"STILBETIN","submission":"DIETHYLSTILBESTROL","actionType":"0.1MG","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"STILBETIN","submission":"DIETHYLSTILBESTROL","actionType":"0.5MG","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"STILBETIN","submission":"DIETHYLSTILBESTROL","actionType":"1MG","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"STILBETIN","submission":"DIETHYLSTILBESTROL","actionType":"5MG","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"STILBETIN","submission":"DIETHYLSTILBESTROL","actionType":"0.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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