B BRAUN FDA Approval NDA 019870

NDA 019870

B BRAUN

FDA Drug Application

Application #019870

Application Sponsors

NDA 019870B BRAUN

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION5GM/100ML;150MG/100ML;130MG/100ML;280MG/100ML;91MG/100ML0ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP1993-06-10STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1995-09-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1998-08-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2000-05-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2000-12-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2002-04-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2002-07-01STANDARD
LABELING; LabelingSUPPL9AP2004-05-11

Submissions Property Types

SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL8Null0

CDER Filings

B BRAUN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19870
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE","strength":"5GM\/100ML;150MG\/100ML;130MG\/100ML;280MG\/100ML;91MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE","actionType":"5GM\/100ML;150MG\/100ML;130MG\/100ML;280MG\/100ML;91MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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