DELCOR ASSET CORP FDA Approval ANDA 083943

ANDA 083943

DELCOR ASSET CORP

FDA Drug Application

Application #083943

Application Sponsors

ANDA 083943DELCOR ASSET CORP

Marketing Status

Discontinued001

Application Products

001CREAM;TOPICAL0.5%0KENALOGTRIAMCINOLONE ACETONIDE

FDA Submissions

ORIG1AP1974-01-29
MANUF (CMC); Manufacturing (CMC)SUPPL19AP1982-06-23
MANUF (CMC); Manufacturing (CMC)SUPPL23AP1982-04-01
MANUF (CMC); Manufacturing (CMC)SUPPL24AP1982-04-01
MANUF (CMC); Manufacturing (CMC)SUPPL26AP1983-05-27
MANUF (CMC); Manufacturing (CMC)SUPPL27AP1984-03-08
MANUF (CMC); Manufacturing (CMC)SUPPL28AP1986-06-06
MANUF (CMC); Manufacturing (CMC)SUPPL31AP1988-02-10
LABELING; LabelingSUPPL34AP1988-04-04
MANUF (CMC); Manufacturing (CMC)SUPPL35AP1996-05-14

Submissions Property Types

ORIG1Null0
SUPPL19Null0
SUPPL23Null0
SUPPL24Null0
SUPPL26Null0
SUPPL27Null0
SUPPL28Null0
SUPPL31Null0
SUPPL34Null0
SUPPL35Null0

CDER Filings

DELCOR ASSET CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83943
            [companyName] => DELCOR ASSET CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"KENALOG","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.5%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"KENALOG","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.5%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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