B BRAUN FDA Approval NDA 019830

NDA 019830

B BRAUN

FDA Drug Application

Application #019830

Documents

Letter2013-02-04
Letter2004-06-25
Label2013-02-06
Letter2020-05-20
Label2020-05-20

Application Sponsors

NDA 019830B BRAUN

Marketing Status

Prescription002
Prescription003
Prescription004

Application Products

002INJECTABLE;INJECTION200MG/100ML0LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDE
003INJECTABLE;INJECTION400MG/100ML0LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDE
004INJECTABLE;INJECTION800MG/100ML0LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP1992-04-08STANDARD
LABELING; LabelingSUPPL2AP1994-03-31STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1998-07-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2001-03-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2002-03-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2002-07-15STANDARD
LABELING; LabelingSUPPL8AP2004-06-24STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2014-08-22STANDARD
LABELING; LabelingSUPPL18AP2013-02-01UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL20AP2017-01-13STANDARD
LABELING; LabelingSUPPL27AP2020-05-19STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL7Null0
SUPPL15Null0
SUPPL18Null6
SUPPL27Null6

TE Codes

002PrescriptionAP
003PrescriptionAP
004PrescriptionAP

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
        )

)

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