BRISTOL MYERS SQUIBB FDA Approval ANDA 083266

ANDA 083266

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #083266

Application Sponsors

ANDA 083266BRISTOL MYERS SQUIBB

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004

Application Products

001TABLET;ORAL0.3MG0AMNESTROGENESTROGENS, ESTERIFIED
002TABLET;ORAL0.625MG0AMNESTROGENESTROGENS, ESTERIFIED
003TABLET;ORAL1.25MG0AMNESTROGENESTROGENS, ESTERIFIED
004TABLET;ORAL2.5MG0AMNESTROGENESTROGENS, ESTERIFIED

CDER Filings

BRISTOL MYERS SQUIBB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83266
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMNESTROGEN","activeIngredients":"ESTROGENS, ESTERIFIED","strength":"0.3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMNESTROGEN","activeIngredients":"ESTROGENS, ESTERIFIED","strength":"0.625MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMNESTROGEN","activeIngredients":"ESTROGENS, ESTERIFIED","strength":"1.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMNESTROGEN","activeIngredients":"ESTROGENS, ESTERIFIED","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMNESTROGEN","submission":"ESTROGENS, ESTERIFIED","actionType":"0.3MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMNESTROGEN","submission":"ESTROGENS, ESTERIFIED","actionType":"0.625MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMNESTROGEN","submission":"ESTROGENS, ESTERIFIED","actionType":"1.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMNESTROGEN","submission":"ESTROGENS, ESTERIFIED","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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