ANDA 083015

ASTELLAS

FDA Drug Application

Application #083015

Application Sponsors

ANDA 083015

ASTELLAS

Marketing Status

• Discontinued: 002
• Discontinued: 003

Application Products

002	CREAM;TOPICAL	0.5%	0	ARISTOCORT	TRIAMCINOLONE ACETONIDE
003	CREAM;TOPICAL	0.5%	0	ARISTOCORT A	TRIAMCINOLONE ACETONIDE

FDA Submissions

	ORIG	1	AP	1972-07-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1983-12-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1987-04-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1987-04-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1992-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1995-04-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1997-07-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	1998-10-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	1998-10-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1998-10-08

Submissions Property Types

SUPPL	36	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	0
SUPPL	47	Null	0
SUPPL	48	Null	0

CDER Filings

ASTELLAS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83015
            [companyName] => ASTELLAS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARISTOCORT","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.5%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ARISTOCORT A","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.5%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ARISTOCORT","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.5%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ARISTOCORT A","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.5%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)