ANDA 060578

DELCOR ASSET CORP

FDA Drug Application

Application #060578

Application Sponsors

ANDA 060578

DELCOR ASSET CORP

Marketing Status

• Discontinued: 001

Application Products

001

POWDER;TOPICAL

100,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

0

MYCOSTATIN

NYSTATIN

FDA Submissions

	ORIG	1	AP	1964-09-08
LABELING; Labeling	SUPPL	3	AP	1998-09-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1992-06-19
LABELING; Labeling	SUPPL	6	AP	1992-11-30

Submissions Property Types

ORIG	1	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0

CDER Filings

DELCOR ASSET CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 60578
            [companyName] => DELCOR ASSET CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCOSTATIN","activeIngredients":"NYSTATIN","strength":"100,000 UNITS\/GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"POWDER;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MYCOSTATIN","submission":"NYSTATIN","actionType":"100,000 UNITS\/GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"POWDER;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)