ANDA 083017

ASTELLAS

FDA Drug Application

Application #083017

Application Sponsors

ANDA 083017

ASTELLAS

Marketing Status

• Discontinued: 003
• Discontinued: 004

Application Products

003	CREAM;TOPICAL	0.025%	0	ARISTOCORT	TRIAMCINOLONE ACETONIDE
004	CREAM;TOPICAL	0.025%	0	ARISTOCORT A	TRIAMCINOLONE ACETONIDE

FDA Submissions

	ORIG	1	AP	1972-07-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1984-02-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1987-04-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1987-04-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1992-06-29

Submissions Property Types

SUPPL	33	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	39	Null	0

CDER Filings

ASTELLAS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83017
            [companyName] => ASTELLAS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARISTOCORT","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.025%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ARISTOCORT A","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.025%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ARISTOCORT","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.025%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ARISTOCORT A","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.025%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)