ANDA 060576

DELCOR ASSET CORP

FDA Drug Application

Application #060576

Application Sponsors

ANDA 060576

DELCOR ASSET CORP

Marketing Status

• Discontinued: 002

Application Products

002

CREAM;TOPICAL

100,000 UNITS/GM;0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons*

0

MYCOLOG-II

NYSTATIN; TRIAMCINOLONE ACETONIDE

FDA Submissions

ORIG

1

AP

1985-05-01

CDER Filings

DELCOR ASSET CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 60576
            [companyName] => DELCOR ASSET CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCOLOG-II","activeIngredients":"NYSTATIN; TRIAMCINOLONE ACETONIDE","strength":"100,000 UNITS\/GM;0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons*","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MYCOLOG-II","submission":"NYSTATIN; TRIAMCINOLONE ACETONIDE","actionType":"100,000 UNITS\/GM;0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons*","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)