NDA 011745

ROCHE

FDA Drug Application

Application #011745

Application Sponsors

NDA 011745

ROCHE

Marketing Status

• Discontinued: 001
• Discontinued: 003

Application Products

001	INJECTABLE;INJECTION	1MG/0.5ML	0	KONAKION	PHYTONADIONE
003	INJECTABLE;INJECTION	10MG/ML	0	KONAKION	PHYTONADIONE

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 11745
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"KONAKION","activeIngredients":"PHYTONADIONE","strength":"1MG\/0.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"KONAKION","activeIngredients":"PHYTONADIONE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"KONAKION","submission":"PHYTONADIONE","actionType":"1MG\/0.5ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"KONAKION","submission":"PHYTONADIONE","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)