BRISTOL MYERS SQUIBB FDA Approval NDA 005657

NDA 005657

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #005657

Application Sponsors

NDA 005657BRISTOL MYERS SQUIBB

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION3MG/ML0TUBOCURARINE CHLORIDETUBOCURARINE CHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1945-02-20PRIORITY
LABELING; LabelingSUPPL2AP1976-12-16PRIORITY
LABELING; LabelingSUPPL3AP1977-02-16PRIORITY
LABELING; LabelingSUPPL4AP1980-04-29PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1980-07-28PRIORITY
LABELING; LabelingSUPPL6AP1985-08-19PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1985-07-22PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1986-11-14PRIORITY
LABELING; LabelingSUPPL9AP1987-06-10PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1992-11-06PRIORITY

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0

CDER Filings

BRISTOL MYERS SQUIBB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 5657
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"TUBOCURARINE CHLORIDE","activeIngredients":"TUBOCURARINE CHLORIDE","strength":"3MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TUBOCURARINE CHLORIDE","submission":"TUBOCURARINE CHLORIDE","actionType":"3MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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