ANDA 083016

ASTELLAS

FDA Drug Application

Application #083016

Application Sponsors

ANDA 083016

ASTELLAS

Marketing Status

• Discontinued: 004
• Discontinued: 005

Application Products

004	CREAM;TOPICAL	0.1%	0	ARISTOCORT	TRIAMCINOLONE ACETONIDE
005	CREAM;TOPICAL	0.1%	0	ARISTOCORT A	TRIAMCINOLONE ACETONIDE

FDA Submissions

	ORIG	1	AP	1972-07-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1984-02-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1992-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1989-10-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1989-10-06
LABELING; Labeling	SUPPL	44	AP	1989-11-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1995-04-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	1997-07-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1998-10-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	1998-10-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1998-10-08

Submissions Property Types

SUPPL	37	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	45	Null	0
SUPPL	47	Null	0
SUPPL	48	Null	0
SUPPL	49	Null	0
SUPPL	50	Null	0

CDER Filings

ASTELLAS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83016
            [companyName] => ASTELLAS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARISTOCORT","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ARISTOCORT A","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ARISTOCORT","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.1%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ARISTOCORT A","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.1%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)