DELCOR ASSET CORP FDA Approval NDA 012515

NDA 012515

DELCOR ASSET CORP

FDA Drug Application

Application #012515

Application Sponsors

NDA 012515DELCOR ASSET CORP

Marketing Status

Discontinued001

Application Products

001SYRUP;ORALEQ 4MG BASE/5ML0KENACORTTRIAMCINOLONE DIACETATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP1961-03-21STANDARD
LABELING; LabelingSUPPL10AP2009-03-13
LABELING; LabelingSUPPL12AP1978-11-02
MANUF (CMC); Manufacturing (CMC)SUPPL15AP1979-07-17STANDARD
LABELING; LabelingSUPPL16AP2009-03-13
MANUF (CMC); Manufacturing (CMC)SUPPL17AP1979-08-21STANDARD
LABELING; LabelingSUPPL18AP2009-03-13
MANUF (CMC); Manufacturing (CMC)SUPPL19AP1982-06-30STANDARD
LABELING; LabelingSUPPL21AP1993-09-07

Submissions Property Types

SUPPL15Null0
SUPPL17Null0
SUPPL19Null0

CDER Filings

DELCOR ASSET CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12515
            [companyName] => DELCOR ASSET CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"KENACORT","activeIngredients":"TRIAMCINOLONE DIACETATE","strength":"EQ 4MG BASE\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"KENACORT","submission":"TRIAMCINOLONE DIACETATE","actionType":"EQ 4MG BASE\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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