NDA 011161

ASTELLAS

FDA Drug Application

Application #011161

Application Sponsors

NDA 011161

ASTELLAS

Marketing Status

• Discontinued: 004
• Discontinued: 007
• Discontinued: 009
• Discontinued: 010
• Discontinued: 011

Application Products

004	TABLET;ORAL	2MG	0	ARISTOCORT	TRIAMCINOLONE
007	TABLET;ORAL	4MG	0	ARISTOCORT	TRIAMCINOLONE
009	TABLET;ORAL	1MG	0	ARISTOCORT	TRIAMCINOLONE
010	TABLET;ORAL	16MG	0	ARISTOCORT	TRIAMCINOLONE
011	TABLET;ORAL	8MG	0	ARISTOCORT	TRIAMCINOLONE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1957-12-03	PRIORITY
LABELING; Labeling	SUPPL	39	AP	2009-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1979-08-06	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1981-04-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1982-06-11	PRIORITY
LABELING; Labeling	SUPPL	44	AP	2009-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1986-11-29	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	1986-09-25	PRIORITY
LABELING; Labeling	SUPPL	47	AP	2009-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1994-03-30	PRIORITY
LABELING; Labeling	SUPPL	49	AP	1993-09-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1994-10-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	1999-09-17	PRIORITY

Submissions Property Types

SUPPL	40	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	0
SUPPL	48	Null	0
SUPPL	50	Null	0
SUPPL	51	Null	0

CDER Filings

ASTELLAS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 11161
            [companyName] => ASTELLAS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARISTOCORT","activeIngredients":"TRIAMCINOLONE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ARISTOCORT","activeIngredients":"TRIAMCINOLONE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ARISTOCORT","activeIngredients":"TRIAMCINOLONE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ARISTOCORT","activeIngredients":"TRIAMCINOLONE","strength":"16MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ARISTOCORT","activeIngredients":"TRIAMCINOLONE","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ARISTOCORT","submission":"TRIAMCINOLONE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ARISTOCORT","submission":"TRIAMCINOLONE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ARISTOCORT","submission":"TRIAMCINOLONE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ARISTOCORT","submission":"TRIAMCINOLONE","actionType":"16MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ARISTOCORT","submission":"TRIAMCINOLONE","actionType":"8MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)