ANDA 061533

DELCOR ASSET CORP

FDA Drug Application

Application #061533

Application Sponsors

ANDA 061533

DELCOR ASSET CORP

Marketing Status

• Discontinued: 001

Application Products

001

SUSPENSION;ORAL

100,000 UNITS/ML

0

MYCOSTATIN

NYSTATIN

FDA Submissions

	ORIG	1	AP	1972-02-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1988-03-29
LABELING; Labeling	SUPPL	10	AP	1990-08-21
LABELING; Labeling	SUPPL	11	AP	1992-09-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1992-06-19
LABELING; Labeling	SUPPL	15	AP	1992-11-02
LABELING; Labeling	SUPPL	16	AP	1992-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1994-01-11
LABELING; Labeling	SUPPL	18	AP	1996-04-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1995-10-16

Submissions Property Types

SUPPL	9	Null	0
SUPPL	13	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0

CDER Filings

DELCOR ASSET CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 61533
            [companyName] => DELCOR ASSET CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCOSTATIN","activeIngredients":"NYSTATIN","strength":"100,000 UNITS\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MYCOSTATIN","submission":"NYSTATIN","actionType":"100,000 UNITS\/ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)