ABBOTT FDA Approval ANDA 062413

ANDA 062413

ABBOTT

FDA Drug Application

Application #062413

Application Sponsors

ANDA 062413ABBOTT

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004
Discontinued005
Discontinued006
Discontinued007
Discontinued008
Discontinued009
Discontinued010

Application Products

001INJECTABLE;INJECTIONEQ 1.2MG BASE/ML0GENTAMICIN SULFATEGENTAMICIN SULFATE
002INJECTABLE;INJECTIONEQ 1.4MG BASE/ML0GENTAMICIN SULFATEGENTAMICIN SULFATE
003INJECTABLE;INJECTIONEQ 1.6MG BASE/ML0GENTAMICIN SULFATEGENTAMICIN SULFATE
004INJECTABLE;INJECTIONEQ 1.8MG BASE/ML0GENTAMICIN SULFATEGENTAMICIN SULFATE
005INJECTABLE;INJECTIONEQ 2MG BASE/ML0GENTAMICIN SULFATEGENTAMICIN SULFATE
006INJECTABLE;INJECTIONEQ 60MG BASE/100ML0GENTAMICIN SULFATEGENTAMICIN SULFATE
007INJECTABLE;INJECTIONEQ 70MG BASE/100ML0GENTAMICIN SULFATEGENTAMICIN SULFATE
008INJECTABLE;INJECTIONEQ 80MG BASE/100ML0GENTAMICIN SULFATEGENTAMICIN SULFATE
009INJECTABLE;INJECTIONEQ 90MG BASE/100ML0GENTAMICIN SULFATEGENTAMICIN SULFATE
010INJECTABLE;INJECTIONEQ 100MG BASE/100ML0GENTAMICIN SULFATEGENTAMICIN SULFATE

FDA Submissions

ORIG1AP1983-08-11
LABELING; LabelingSUPPL6AP1993-07-14

CDER Filings

ABBOTT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62413
            [companyName] => ABBOTT
            [docInserts] => ["",""]
            [products] => [{"drugName":"GENTAMICIN SULFATE","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 1.2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 1.4MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 1.6MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 1.8MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 60MG BASE\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 70MG BASE\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 80MG BASE\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 90MG BASE\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENTAMICIN SULFATE","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 100MG BASE\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GENTAMICIN SULFATE","submission":"GENTAMICIN SULFATE","actionType":"EQ 1.2MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE","submission":"GENTAMICIN SULFATE","actionType":"EQ 1.4MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE","submission":"GENTAMICIN SULFATE","actionType":"EQ 1.6MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE","submission":"GENTAMICIN SULFATE","actionType":"EQ 1.8MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE","submission":"GENTAMICIN SULFATE","actionType":"EQ 2MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE","submission":"GENTAMICIN SULFATE","actionType":"EQ 60MG BASE\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE","submission":"GENTAMICIN SULFATE","actionType":"EQ 70MG BASE\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE","submission":"GENTAMICIN SULFATE","actionType":"EQ 80MG BASE\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE","submission":"GENTAMICIN SULFATE","actionType":"EQ 90MG BASE\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENTAMICIN SULFATE","submission":"GENTAMICIN SULFATE","actionType":"EQ 100MG BASE\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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