B BRAUN FDA Approval NDA 019077

NDA 019077

B BRAUN

FDA Drug Application

Application #019077

Application Sponsors

NDA 019077B BRAUN

Marketing Status

Discontinued001

Application Products

001LIQUID;N/A100%0STERILE WATER FOR INJECTION IN PLASTIC CONTAINERSTERILE WATER FOR INJECTION

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP1984-03-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1986-01-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1990-09-11STANDARD

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL4Null0

CDER Filings

B BRAUN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19077
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"STERILE WATER FOR INJECTION IN PLASTIC CONTAINER","activeIngredients":"STERILE WATER FOR INJECTION","strength":"100%","dosageForm":"LIQUID;N\/A","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"STERILE WATER FOR INJECTION IN PLASTIC CONTAINER","submission":"STERILE WATER FOR INJECTION","actionType":"100%","submissionClassification":"LIQUID;N\/A","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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