BRISTOL MYERS SQUIBB FDA Approval NDA 017907

NDA 017907

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #017907

Application Sponsors

NDA 017907BRISTOL MYERS SQUIBB

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTIONN/A0GLUCOSCANTECHNETIUM TC-99M GLUCEPTATE KIT

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1978-05-25STANDARD
LABELING; LabelingSUPPL5AP2007-12-07
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1983-04-19STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1989-05-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1990-03-26STANDARD

Submissions Property Types

SUPPL8Null0
SUPPL10Null0
SUPPL11Null0

CDER Filings

BRISTOL MYERS SQUIBB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17907
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLUCOSCAN","activeIngredients":"TECHNETIUM TC-99M GLUCEPTATE KIT","strength":"N\/A","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GLUCOSCAN","submission":"TECHNETIUM TC-99M GLUCEPTATE KIT","actionType":"N\/A","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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