ANDA 088818

ASTELLAS

FDA Drug Application

Application #088818

Application Sponsors

ANDA 088818

ASTELLAS

Marketing Status

• Discontinued: 001

Application Products

001

CREAM;TOPICAL

0.025%

0

ARISTOCORT A

TRIAMCINOLONE ACETONIDE

FDA Submissions

	ORIG	1	AP	1984-10-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1989-12-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1989-10-06
LABELING; Labeling	SUPPL	4	AP	1989-12-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-05-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-05-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1998-05-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1998-05-06

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0

CDER Filings

ASTELLAS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88818
            [companyName] => ASTELLAS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARISTOCORT A","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.025%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ARISTOCORT A","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.025%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)