NDA 019830

B BRAUN

FDA Drug Application

Application #019830

Documents

• Letter: 2013-02-04
• Letter: 2004-06-25
• Label: 2013-02-06
• Letter: 2020-05-20
• Label: 2020-05-20

Application Sponsors

NDA 019830

B BRAUN

Marketing Status

• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

002	INJECTABLE;INJECTION	200MG/100ML	0	LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE
003	INJECTABLE;INJECTION	400MG/100ML	0	LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE
004	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	1992-04-08	STANDARD
LABELING; Labeling	SUPPL	2	AP	1994-03-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-07-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2001-03-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-07-15	STANDARD
LABELING; Labeling	SUPPL	8	AP	2004-06-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2014-08-22	STANDARD
LABELING; Labeling	SUPPL	18	AP	2013-02-01	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2017-01-13	STANDARD
LABELING; Labeling	SUPPL	27	AP	2020-05-19	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	15	Null	0
SUPPL	18	Null	6
SUPPL	27	Null	6

TE Codes

002	Prescription	AP
003	Prescription	AP
004	Prescription	AP

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19830
            [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":"Prescription","te":"","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":"Prescription","te":"","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":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/19\/2020","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/019830s027lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2013","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019830s018lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER","submission":"LIDOCAINE HYDROCHLORIDE","actionType":"200MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER","submission":"LIDOCAINE HYDROCHLORIDE","actionType":"400MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER","submission":"LIDOCAINE HYDROCHLORIDE","actionType":"800MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2020-05-19
        )

)