NDA 011283

DELCOR ASSET CORP

FDA Drug Application

Application #011283

Application Sponsors

NDA 011283

DELCOR ASSET CORP

Marketing Status

• Discontinued: 003
• Discontinued: 006
• Discontinued: 008
• Discontinued: 010

Application Products

003	TABLET;ORAL	1MG	0	KENACORT	TRIAMCINOLONE
006	TABLET;ORAL	4MG	0	KENACORT	TRIAMCINOLONE
008	TABLET;ORAL	2MG	0	KENACORT	TRIAMCINOLONE
010	TABLET;ORAL	8MG	0	KENACORT	TRIAMCINOLONE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1958-01-14	STANDARD
S; Supplement	SUPPL	3	AP	1968-07-19	STANDARD
LABELING; Labeling	SUPPL	33	AP	1979-07-17
LABELING; Labeling	SUPPL	34	AP	2007-12-07
LABELING; Labeling	SUPPL	35	AP	2007-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1979-07-17	STANDARD
LABELING; Labeling	SUPPL	38	AP	1979-06-04
LABELING; Labeling	SUPPL	39	AP	2007-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1979-08-21	STANDARD
LABELING; Labeling	SUPPL	42	AP	2007-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1987-11-30	STANDARD
LABELING; Labeling	SUPPL	44	AP	1993-09-07

Submissions Property Types

SUPPL	3	Null	0
SUPPL	37	Null	0
SUPPL	40	Null	0
SUPPL	43	Null	0

CDER Filings

DELCOR ASSET CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 11283
            [companyName] => DELCOR ASSET CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"KENACORT","activeIngredients":"TRIAMCINOLONE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"KENACORT","activeIngredients":"TRIAMCINOLONE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"KENACORT","activeIngredients":"TRIAMCINOLONE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"KENACORT","activeIngredients":"TRIAMCINOLONE","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"KENACORT","submission":"TRIAMCINOLONE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"KENACORT","submission":"TRIAMCINOLONE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"KENACORT","submission":"TRIAMCINOLONE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"KENACORT","submission":"TRIAMCINOLONE","actionType":"8MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)