GLAXOSMITHKLINE FDA Approval ANDA 060666

ANDA 060666

GLAXOSMITHKLINE

FDA Drug Application

Application #060666

Documents

Review2006-04-20

Application Sponsors

ANDA 060666GLAXOSMITHKLINE

Marketing Status

Discontinued001
Discontinued002

Application Products

001FOR SUSPENSION;ORALEQ 125MG BASE/5ML0TOTACILLINAMPICILLIN/AMPICILLIN TRIHYDRATE
002FOR SUSPENSION;ORALEQ 250MG BASE/5ML0TOTACILLINAMPICILLIN/AMPICILLIN TRIHYDRATE

FDA Submissions

ORIG1AP1970-05-07

CDER Filings

GLAXOSMITHKLINE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 60666
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOTACILLIN","activeIngredients":"AMPICILLIN\/AMPICILLIN TRIHYDRATE","strength":"EQ 125MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TOTACILLIN","activeIngredients":"AMPICILLIN\/AMPICILLIN TRIHYDRATE","strength":"EQ 250MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TOTACILLIN","submission":"AMPICILLIN\/AMPICILLIN TRIHYDRATE","actionType":"EQ 125MG BASE\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TOTACILLIN","submission":"AMPICILLIN\/AMPICILLIN TRIHYDRATE","actionType":"EQ 250MG BASE\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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