B BRAUN FDA Approval NDA 018722

NDA 018722

B BRAUN

FDA Drug Application

Application #018722

Application Sponsors

NDA 018722B BRAUN

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004

Application Products

001INJECTABLE;INJECTION75MG/100ML;900MG/100ML0SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINERPOTASSIUM CHLORIDE; SODIUM CHLORIDE
002INJECTABLE;INJECTION150MG/100ML;900MG/100ML0SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINERPOTASSIUM CHLORIDE; SODIUM CHLORIDE
003INJECTABLE;INJECTION220MG/100ML;900MG/100ML0SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINERPOTASSIUM CHLORIDE; SODIUM CHLORIDE
004INJECTABLE;INJECTION300MG/100ML;900MG/100ML0SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINERPOTASSIUM CHLORIDE; SODIUM CHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP1982-11-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1985-04-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1985-04-03STANDARD
LABELING; LabelingSUPPL4AP1985-05-24STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1990-09-11STANDARD

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL6Null0

CDER Filings

B BRAUN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18722
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER","activeIngredients":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"75MG\/100ML;900MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER","activeIngredients":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"150MG\/100ML;900MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER","activeIngredients":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"220MG\/100ML;900MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER","activeIngredients":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","strength":"300MG\/100ML;900MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER","submission":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"75MG\/100ML;900MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER","submission":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"150MG\/100ML;900MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER","submission":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"220MG\/100ML;900MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER","submission":"POTASSIUM CHLORIDE; SODIUM CHLORIDE","actionType":"300MG\/100ML;900MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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