ROCHE FDA Approval NDA 050565

NDA 050565

ROCHE

FDA Drug Application

Application #050565

Application Sponsors

NDA 050565ROCHE

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001INJECTABLE;INJECTION250MG/VIAL0COACTINAMDINOCILLIN
002INJECTABLE;INJECTION500MG/VIAL0COACTINAMDINOCILLIN
003INJECTABLE;INJECTION1GM/VIAL0COACTINAMDINOCILLIN

CDER Filings

ROCHE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50565
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"COACTIN","activeIngredients":"AMDINOCILLIN","strength":"250MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"COACTIN","activeIngredients":"AMDINOCILLIN","strength":"500MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"COACTIN","activeIngredients":"AMDINOCILLIN","strength":"1GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"COACTIN","submission":"AMDINOCILLIN","actionType":"250MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"COACTIN","submission":"AMDINOCILLIN","actionType":"500MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"COACTIN","submission":"AMDINOCILLIN","actionType":"1GM\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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