IDT AUSTRALIA LTD FDA Approval ANDA 073586

ANDA 073586

IDT AUSTRALIA LTD

FDA Drug Application

Application #073586

Application Sponsors

ANDA 073586IDT AUSTRALIA LTD

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL10MG;100MG0CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPA

FDA Submissions

ORIG1AP1995-06-29
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1997-01-08
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1997-01-08
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1997-08-11
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1997-11-06

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0

CDER Filings

IDT AUSTRALIA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 73586
            [companyName] => IDT AUSTRALIA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBIDOPA AND LEVODOPA","activeIngredients":"CARBIDOPA; LEVODOPA","strength":"10MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CARBIDOPA AND LEVODOPA","submission":"CARBIDOPA; LEVODOPA","actionType":"10MG;100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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