NDA 011960

ASTELLAS

FDA Drug Application

Application #011960

Application Sponsors

NDA 011960

ASTELLAS

Marketing Status

• Discontinued: 004

Application Products

004

SYRUP;ORAL

2MG/5ML

0

ARISTOCORT

TRIAMCINOLONE DIACETATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1959-09-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1979-02-26	STANDARD
LABELING; Labeling	SUPPL	12	AP	1993-11-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1992-02-06	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0

CDER Filings

ASTELLAS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 11960
            [companyName] => ASTELLAS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARISTOCORT","activeIngredients":"TRIAMCINOLONE DIACETATE","strength":"2MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ARISTOCORT","submission":"TRIAMCINOLONE DIACETATE","actionType":"2MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)