ABBOTT FDA Approval NDA 019005

NDA 019005

ABBOTT

FDA Drug Application

Application #019005

Application Sponsors

NDA 019005ABBOTT

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001INJECTABLE;INJECTION800MG/100ML0BRETYLIUM TOSYLATE IN DEXTROSE 5%BRETYLIUM TOSYLATE
002INJECTABLE;INJECTION200MG/100ML0BRETYLIUM TOSYLATE IN DEXTROSE 5%BRETYLIUM TOSYLATE
003INJECTABLE;INJECTION400MG/100ML0BRETYLIUM TOSYLATE IN DEXTROSE 5%BRETYLIUM TOSYLATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP1986-04-16STANDARD

CDER Filings

ABBOTT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19005
            [companyName] => ABBOTT
            [docInserts] => ["",""]
            [products] => [{"drugName":"BRETYLIUM TOSYLATE IN DEXTROSE 5%","activeIngredients":"BRETYLIUM TOSYLATE","strength":"800MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BRETYLIUM TOSYLATE IN DEXTROSE 5%","activeIngredients":"BRETYLIUM TOSYLATE","strength":"200MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BRETYLIUM TOSYLATE IN DEXTROSE 5%","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%","submission":"BRETYLIUM TOSYLATE","actionType":"800MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BRETYLIUM TOSYLATE IN DEXTROSE 5%","submission":"BRETYLIUM TOSYLATE","actionType":"200MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BRETYLIUM TOSYLATE IN DEXTROSE 5%","submission":"BRETYLIUM TOSYLATE","actionType":"400MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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