NDA 050619

DELCOR ASSET CORP

FDA Drug Application

Application #050619

Documents

• Letter: 2003-05-29

Application Sponsors

NDA 050619

DELCOR ASSET CORP

Marketing Status

• Discontinued: 001

Application Products

001

PASTILLE;ORAL

200,000 UNITS

0

MYCOSTATIN

NYSTATIN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1987-04-09	STANDARD
LABELING; Labeling	SUPPL	2	AP	1998-11-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-02-11	STANDARD
LABELING; Labeling	SUPPL	4	AP	2003-04-30	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0

CDER Filings

DELCOR ASSET CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50619
            [companyName] => DELCOR ASSET CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCOSTATIN","activeIngredients":"NYSTATIN","strength":"200,000 UNITS","dosageForm":"PASTILLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MYCOSTATIN","submission":"NYSTATIN","actionType":"200,000 UNITS","submissionClassification":"PASTILLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)