BRISTOL MYERS SQUIBB FDA Approval ANDA 070867

ANDA 070867

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #070867

Application Sponsors

ANDA 070867BRISTOL MYERS SQUIBB

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION5MG/VIAL0VINCREXVINCRISTINE SULFATE

FDA Submissions

ORIG1AP1988-07-12
LABELING; LabelingSUPPL2AP1991-04-17

CDER Filings

BRISTOL MYERS SQUIBB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70867
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"VINCREX","activeIngredients":"VINCRISTINE SULFATE","strength":"5MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VINCREX","submission":"VINCRISTINE SULFATE","actionType":"5MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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