B BRAUN FDA Approval NDA 019121

NDA 019121

B BRAUN

FDA Drug Application

Application #019121

Application Sponsors

NDA 019121B BRAUN

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001INJECTABLE;INJECTION100MG/100ML0BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINERBRETYLIUM TOSYLATE
002INJECTABLE;INJECTION200MG/100ML0BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINERBRETYLIUM TOSYLATE
003INJECTABLE;INJECTION400MG/100ML0BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINERBRETYLIUM TOSYLATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP1986-04-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1990-07-13STANDARD
LABELING; LabelingSUPPL3AP1993-10-06STANDARD

Submissions Property Types

SUPPL2Null0

CDER Filings

B BRAUN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19121
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"BRETYLIUM TOSYLATE","strength":"100MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"BRETYLIUM TOSYLATE","strength":"200MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"BRETYLIUM TOSYLATE","strength":"400MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"BRETYLIUM TOSYLATE","actionType":"100MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"BRETYLIUM TOSYLATE","actionType":"200MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"BRETYLIUM TOSYLATE","actionType":"400MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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