B BRAUN FDA Approval NDA 018229

NDA 018229

B BRAUN

FDA Drug Application

Application #018229

Application Sponsors

NDA 018229B BRAUN

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION10GM/100ML;450MG/100ML0DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERDEXTROSE; SODIUM CHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP1979-06-28STANDARD
LABELING; LabelingSUPPL2AP1979-10-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1980-02-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1980-08-06STANDARD
LABELING; LabelingSUPPL6AP1983-01-24STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1981-03-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1981-10-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1986-02-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1985-06-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1985-04-03STANDARD
LABELING; LabelingSUPPL12AP1985-08-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1990-09-11STANDARD

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL14Null0

CDER Filings

B BRAUN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18229
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"10GM\/100ML;450MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER","submission":"DEXTROSE; SODIUM CHLORIDE","actionType":"10GM\/100ML;450MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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