NDA 019005

ABBOTT

FDA Drug Application

Application #019005

Application Sponsors

NDA 019005

ABBOTT

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	INJECTABLE;INJECTION	800MG/100ML	0	BRETYLIUM TOSYLATE IN DEXTROSE 5%	BRETYLIUM TOSYLATE
002	INJECTABLE;INJECTION	200MG/100ML	0	BRETYLIUM TOSYLATE IN DEXTROSE 5%	BRETYLIUM TOSYLATE
003	INJECTABLE;INJECTION	400MG/100ML	0	BRETYLIUM TOSYLATE IN DEXTROSE 5%	BRETYLIUM TOSYLATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

1986-04-16

STANDARD

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
        )

)