BRISTOL MYERS SQUIBB FDA Approval NDA 016911

NDA 016911

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #016911

Application Sponsors

NDA 016911BRISTOL MYERS SQUIBB

Marketing Status

Discontinued001
Discontinued002

Application Products

001SOLUTION;INTRAMUSCULAR125MG/ML (125MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1DELALUTINHYDROXYPROGESTERONE CAPROATE
002SOLUTION;INTRAMUSCULAR250MG/ML (250MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1DELALUTINHYDROXYPROGESTERONE CAPROATE

CDER Filings

BRISTOL MYERS SQUIBB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16911
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"DELALUTIN","activeIngredients":"HYDROXYPROGESTERONE CAPROATE","strength":"125MG\/ML (125MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SOLUTION;INTRAMUSCULAR","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"DELALUTIN","activeIngredients":"HYDROXYPROGESTERONE CAPROATE","strength":"250MG\/ML (250MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SOLUTION;INTRAMUSCULAR","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DELALUTIN","submission":"HYDROXYPROGESTERONE CAPROATE","actionType":"125MG\/ML (125MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SOLUTION;INTRAMUSCULAR","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"DELALUTIN","submission":"HYDROXYPROGESTERONE CAPROATE","actionType":"250MG\/ML (250MG\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SOLUTION;INTRAMUSCULAR","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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