ANDA 080750

ASTELLAS

FDA Drug Application

Application #080750

Application Sponsors

ANDA 080750

ASTELLAS

Marketing Status

• Discontinued: 003
• Discontinued: 004

Application Products

003	OINTMENT;TOPICAL	0.1%	0	ARISTOCORT A	TRIAMCINOLONE ACETONIDE
004	OINTMENT;TOPICAL	0.1%	0	ARISTOCORT	TRIAMCINOLONE ACETONIDE

FDA Submissions

	ORIG	1	AP	1972-04-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1982-03-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1982-03-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1982-03-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1982-03-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1983-12-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1989-10-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1989-10-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1989-10-13
LABELING; Labeling	SUPPL	37	AP	1989-10-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1995-04-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1997-07-16

Submissions Property Types

SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	32	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0

CDER Filings

ASTELLAS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80750
            [companyName] => ASTELLAS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARISTOCORT","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.1%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ARISTOCORT A","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.1%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ARISTOCORT","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.1%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ARISTOCORT A","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.1%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)