B BRAUN FDA Approval NDA 018186

NDA 018186

B BRAUN

FDA Drug Application

Application #018186

Application Sponsors

NDA 018186B BRAUN

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION1.87GM/100ML0SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINERSODIUM LACTATE

FDA Submissions

ORIG1AP1979-06-15
LABELING; LabelingSUPPL2AP1979-10-09
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1980-02-12
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1980-08-06
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1980-10-24
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1980-09-25
LABELING; LabelingSUPPL7AP1983-01-24
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1981-02-24
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1981-10-26
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1986-02-18
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1985-06-28
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1985-04-03
LABELING; LabelingSUPPL13AP1985-06-24
MANUF (CMC); Manufacturing (CMC)SUPPL15AP1990-09-11
LABELING; LabelingSUPPL16AP1993-03-24

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL15Null0
SUPPL16Null0

CDER Filings

B BRAUN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18186
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER","activeIngredients":"SODIUM LACTATE","strength":"1.87GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER","submission":"SODIUM LACTATE","actionType":"1.87GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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