ANDA 080745

ASTELLAS

FDA Drug Application

Application #080745

Application Sponsors

ANDA 080745

ASTELLAS

Marketing Status

• Discontinued: 002
• Discontinued: 003

Application Products

002	OINTMENT;TOPICAL	0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	ARISTOCORT	TRIAMCINOLONE ACETONIDE
003	OINTMENT;TOPICAL	0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	ARISTOCORT A	TRIAMCINOLONE ACETONIDE

FDA Submissions

	ORIG	1	AP	1972-04-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1983-12-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1989-10-13
LABELING; Labeling	SUPPL	25	AP	1989-10-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1989-10-13

Submissions Property Types

SUPPL	22	Null	0
SUPPL	24	Null	0
SUPPL	26	Null	0

CDER Filings

ASTELLAS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80745
            [companyName] => ASTELLAS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARISTOCORT","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ARISTOCORT A","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ARISTOCORT","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ARISTOCORT A","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)