IDT AUSTRALIA LTD FDA Approval ANDA 087561

ANDA 087561

IDT AUSTRALIA LTD

FDA Drug Application

Application #087561

Application Sponsors

ANDA 087561IDT AUSTRALIA LTD

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL75MG0DIPYRIDAMOLEDIPYRIDAMOLE

FDA Submissions

ORIG1AP1992-02-25
LABELING; LabelingSUPPL18AP1992-02-25

CDER Filings

IDT AUSTRALIA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87561
            [companyName] => IDT AUSTRALIA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIPYRIDAMOLE","activeIngredients":"DIPYRIDAMOLE","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DIPYRIDAMOLE","submission":"DIPYRIDAMOLE","actionType":"75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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