ABBVIE FDA Approval NDA 006044

NDA 006044

ABBVIE

FDA Drug Application

Application #006044

Application Sponsors

NDA 006044ABBVIE

Marketing Status

Discontinued003

Application Products

003TABLET, DELAYED RELEASE;ORAL165MG0DIASONE SODIUMSULFOXONE SODIUM

FDA Submissions

S; SupplementSUPPL4AP1974-05-24
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1979-11-27
LABELING; LabelingSUPPL10AP1986-03-17

Submissions Property Types

SUPPL4Null0
SUPPL6Null0

CDER Filings

ABBVIE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 6044
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIASONE SODIUM","activeIngredients":"SULFOXONE SODIUM","strength":"165MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DIASONE SODIUM","submission":"SULFOXONE SODIUM","actionType":"165MG","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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