NDA 019121

B BRAUN

FDA Drug Application

Application #019121

Application Sponsors

NDA 019121

B BRAUN

Marketing Status

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

Application Products

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

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1986-04-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1990-07-13	STANDARD
LABELING; Labeling	SUPPL	3	AP	1993-10-06	STANDARD

Submissions Property Types

SUPPL

2

Null

0

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
        )

)