NDA 018967

B BRAUN

FDA Drug Application

Application #018967

Application Sponsors

NDA 018967

B BRAUN

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	200MG/100ML	0	LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE
002	INJECTABLE;INJECTION	400MG/100ML	0	LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE
003	INJECTABLE;INJECTION	800MG/100ML	0	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1984-03-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1990-09-11	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	3	Null	0

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18967
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"LIDOCAINE HYDROCHLORIDE","strength":"200MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"LIDOCAINE HYDROCHLORIDE","strength":"400MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"LIDOCAINE HYDROCHLORIDE","strength":"800MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER","submission":"LIDOCAINE HYDROCHLORIDE","actionType":"200MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER","submission":"LIDOCAINE HYDROCHLORIDE","actionType":"400MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER","submission":"LIDOCAINE HYDROCHLORIDE","actionType":"800MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)