B BRAUN FDA Approval ANDA 062814

ANDA 062814

B BRAUN

FDA Drug Application

Application #062814

Application Sponsors

ANDA 062814B BRAUN

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004
Discontinued005
Discontinued006
Discontinued007
Discontinued008
Discontinued009
Discontinued010
Discontinued011
Discontinued012
Discontinued013
Discontinued014

Application Products

001INJECTABLE;INJECTIONEQ 0.8MG BASE/ML0GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATE
002INJECTABLE;INJECTIONEQ 1.2MG BASE/ML0GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATE
003INJECTABLE;INJECTIONEQ 1.4MG BASE/ML0GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATE
004INJECTABLE;INJECTIONEQ 1.6MG BASE/ML0GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATE
005INJECTABLE;INJECTIONEQ 1.8MG BASE/ML0GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATE
006INJECTABLE;INJECTIONEQ 2MG BASE/ML0GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATE
007INJECTABLE;INJECTIONEQ 2.4MG BASE/ML0GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATE
008INJECTABLE;INJECTIONEQ 40MG BASE/100ML0GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATE
009INJECTABLE;INJECTIONEQ 60MG BASE/100ML0GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATE
010INJECTABLE;INJECTIONEQ 70MG BASE/100ML0GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATE
011INJECTABLE;INJECTIONEQ 80MG BASE/100ML0GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATE
012INJECTABLE;INJECTIONEQ 90MG BASE/100ML0GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATE
013INJECTABLE;INJECTIONEQ 100MG BASE/100ML0GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATE
014INJECTABLE;INJECTIONEQ 120MG BASE/100ML0GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATE

FDA Submissions

ORIG1AP1987-08-28
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1992-01-29
LABELING; LabelingSUPPL5AP1992-11-18
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1996-03-01
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1997-05-16
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2001-08-03
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2001-08-21
LABELING; LabelingSUPPL12AP2004-08-31
LABELING; LabelingSUPPL13AP2005-06-07
LABELING; LabelingSUPPL15AP2006-12-07
LABELING; LabelingSUPPL16AP2007-09-12
LABELING; LabelingSUPPL17AP2008-11-20
LABELING; LabelingSUPPL18AP2009-11-30
LABELING; LabelingSUPPL21AP2010-05-13

Submissions Property Types

SUPPL4Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL18Null7

CDER Filings

B BRAUN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62814
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 0.8MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 1.2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 1.4MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 1.6MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 1.8MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 2.4MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 40MG BASE\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 60MG BASE\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 70MG BASE\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 80MG BASE\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 90MG BASE\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 100MG BASE\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 120MG BASE\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 0.8MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 1.2MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 1.4MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 1.6MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 1.8MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 2MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 2.4MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 40MG BASE\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 60MG BASE\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 70MG BASE\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 80MG BASE\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 90MG BASE\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 100MG BASE\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"GENTAMICIN SULFATE","actionType":"EQ 120MG BASE\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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