DELCOR ASSET CORP FDA Approval ANDA 084343

ANDA 084343

DELCOR ASSET CORP

FDA Drug Application

Application #084343

Application Sponsors

ANDA 084343DELCOR ASSET CORP

Marketing Status

Discontinued001
Discontinued002

Application Products

001LOTION;TOPICAL0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**0KENALOGTRIAMCINOLONE ACETONIDE
002LOTION;TOPICAL0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**0KENALOGTRIAMCINOLONE ACETONIDE

FDA Submissions

ORIG1AP1974-07-16
MANUF (CMC); Manufacturing (CMC)SUPPL17AP1981-12-21
MANUF (CMC); Manufacturing (CMC)SUPPL18AP1981-12-21
MANUF (CMC); Manufacturing (CMC)SUPPL21AP1981-12-21
MANUF (CMC); Manufacturing (CMC)SUPPL22AP1982-06-21
MANUF (CMC); Manufacturing (CMC)SUPPL23AP1982-12-01
MANUF (CMC); Manufacturing (CMC)SUPPL24AP1983-05-05
MANUF (CMC); Manufacturing (CMC)SUPPL25AP1983-06-28
MANUF (CMC); Manufacturing (CMC)SUPPL31AP1992-11-09

Submissions Property Types

ORIG1Null0
SUPPL17Null0
SUPPL18Null0
SUPPL21Null0
SUPPL22Null0
SUPPL23Null0
SUPPL24Null0
SUPPL25Null0
SUPPL31Null0

CDER Filings

DELCOR ASSET CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84343
            [companyName] => DELCOR ASSET CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"KENALOG","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"LOTION;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"KENALOG","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"LOTION;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"KENALOG","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"LOTION;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"KENALOG","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"LOTION;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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