IDT AUSTRALIA LTD FDA Approval ANDA 089221

ANDA 089221

IDT AUSTRALIA LTD

FDA Drug Application

Application #089221

Application Sponsors

ANDA 089221IDT AUSTRALIA LTD

Marketing Status

Discontinued001

Application Products

001CAPSULE;ORAL500MG0PROCAINAMIDE HYDROCHLORIDEPROCAINAMIDE HYDROCHLORIDE

FDA Submissions

ORIG1AP1986-07-01
LABELING; LabelingSUPPL4AP1988-10-20
LABELING; LabelingSUPPL5AP1991-02-14

CDER Filings

IDT AUSTRALIA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89221
            [companyName] => IDT AUSTRALIA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROCAINAMIDE HYDROCHLORIDE","activeIngredients":"PROCAINAMIDE HYDROCHLORIDE","strength":"500MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROCAINAMIDE HYDROCHLORIDE","submission":"PROCAINAMIDE HYDROCHLORIDE","actionType":"500MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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