BRISTOL MYERS SQUIBB FDA Approval ANDA 085911

ANDA 085911

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #085911

Application Sponsors

ANDA 085911BRISTOL MYERS SQUIBB

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL500MG;5MG0OXYCODONE 5/APAP 500ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

FDA Submissions

ORIG1AP1977-10-25

CDER Filings

BRISTOL MYERS SQUIBB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85911
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCODONE 5\/APAP 500","activeIngredients":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","strength":"500MG;5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OXYCODONE 5\/APAP 500","submission":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","actionType":"500MG;5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.