B BRAUN FDA Approval NDA 018046

NDA 018046

B BRAUN

FDA Drug Application

Application #018046

Application Sponsors

NDA 018046B BRAUN

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION10GM/100ML0DEXTROSE 10% IN PLASTIC CONTAINERDEXTROSE

FDA Submissions

ORIG1AP1978-02-21
LABELING; LabelingSUPPL2AP1978-09-29
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1978-11-30
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1979-06-07
LABELING; LabelingSUPPL5AP1979-06-07
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1979-06-08
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1979-10-16
LABELING; LabelingSUPPL8AP1979-10-09
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1980-02-12
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1980-07-16
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1980-08-06
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1980-10-24
LABELING; LabelingSUPPL13AP1983-01-24
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1981-10-26
MANUF (CMC); Manufacturing (CMC)SUPPL15AP1986-02-18
MANUF (CMC); Manufacturing (CMC)SUPPL16AP1985-05-17
MANUF (CMC); Manufacturing (CMC)SUPPL17AP1985-04-03
LABELING; LabelingSUPPL18AP1985-06-25
MANUF (CMC); Manufacturing (CMC)SUPPL20AP1990-09-11

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL16Null0
SUPPL17Null0
SUPPL18Null0
SUPPL20Null0

CDER Filings

B BRAUN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18046
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROSE 10% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE","strength":"10GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXTROSE 10% IN PLASTIC CONTAINER","submission":"DEXTROSE","actionType":"10GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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