GLAXOSMITHKLINE FDA Approval ANDA 060677

ANDA 060677

GLAXOSMITHKLINE

FDA Drug Application

Application #060677

Application Sponsors

ANDA 060677GLAXOSMITHKLINE

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004
Discontinued005
Discontinued006

Application Products

001INJECTABLE;INJECTIONEQ 125MG BASE/VIAL0TOTACILLIN-NAMPICILLIN SODIUM
002INJECTABLE;INJECTIONEQ 250MG BASE/VIAL0TOTACILLIN-NAMPICILLIN SODIUM
003INJECTABLE;INJECTIONEQ 500MG BASE/VIAL0TOTACILLIN-NAMPICILLIN SODIUM
004INJECTABLE;INJECTIONEQ 1GM BASE/VIAL0TOTACILLIN-NAMPICILLIN SODIUM
005INJECTABLE;INJECTIONEQ 2GM BASE/VIAL0TOTACILLIN-NAMPICILLIN SODIUM
006INJECTABLE;INJECTIONEQ 10GM BASE/VIAL0TOTACILLIN-NAMPICILLIN SODIUM

CDER Filings

GLAXOSMITHKLINE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 60677
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOTACILLIN-N","activeIngredients":"AMPICILLIN SODIUM","strength":"EQ 125MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TOTACILLIN-N","activeIngredients":"AMPICILLIN SODIUM","strength":"EQ 250MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TOTACILLIN-N","activeIngredients":"AMPICILLIN SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TOTACILLIN-N","activeIngredients":"AMPICILLIN SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TOTACILLIN-N","activeIngredients":"AMPICILLIN SODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TOTACILLIN-N","activeIngredients":"AMPICILLIN SODIUM","strength":"EQ 10GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TOTACILLIN-N","submission":"AMPICILLIN SODIUM","actionType":"EQ 125MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TOTACILLIN-N","submission":"AMPICILLIN SODIUM","actionType":"EQ 250MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TOTACILLIN-N","submission":"AMPICILLIN SODIUM","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TOTACILLIN-N","submission":"AMPICILLIN SODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TOTACILLIN-N","submission":"AMPICILLIN SODIUM","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TOTACILLIN-N","submission":"AMPICILLIN SODIUM","actionType":"EQ 10GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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