GLAXOSMITHKLINE FDA Approval ANDA 084060

ANDA 084060

GLAXOSMITHKLINE

FDA Drug Application

Application #084060

Application Sponsors

ANDA 084060GLAXOSMITHKLINE

Marketing Status

Discontinued001
Discontinued002

Application Products

001INJECTABLE;INJECTION1MG/0.5ML0PHYTONADIONEPHYTONADIONE
002INJECTABLE;INJECTION10MG/ML0PHYTONADIONEPHYTONADIONE

CDER Filings

GLAXOSMITHKLINE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84060
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHYTONADIONE","activeIngredients":"PHYTONADIONE","strength":"1MG\/0.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PHYTONADIONE","activeIngredients":"PHYTONADIONE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PHYTONADIONE","submission":"PHYTONADIONE","actionType":"1MG\/0.5ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PHYTONADIONE","submission":"PHYTONADIONE","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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