DELCOR ASSET CORP FDA Approval ANDA 060574

ANDA 060574

DELCOR ASSET CORP

FDA Drug Application

Application #060574

Application Sponsors

ANDA 060574DELCOR ASSET CORP

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL500,000 UNITS0MYCOSTATINNYSTATIN

FDA Submissions

ORIG1AP1964-09-16
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1992-06-23
LABELING; LabelingSUPPL12AP1992-12-07
LABELING; LabelingSUPPL13AP1996-04-11
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1995-11-27

Submissions Property Types

ORIG1Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0

CDER Filings

DELCOR ASSET CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 60574
            [companyName] => DELCOR ASSET CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCOSTATIN","activeIngredients":"NYSTATIN","strength":"500,000 UNITS","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MYCOSTATIN","submission":"NYSTATIN","actionType":"500,000 UNITS","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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