NDA 018116

ASTELLAS

FDA Drug Application

Application #018116

Application Sponsors

NDA 018116

ASTELLAS

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	CREAM;TOPICAL	0.025%	1	CYCLOCORT	AMCINONIDE
002	CREAM;TOPICAL	0.1%	1	CYCLOCORT	AMCINONIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1979-10-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-05-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-08-26	STANDARD
LABELING; Labeling	SUPPL	4	AP	2009-03-13
LABELING; Labeling	SUPPL	5	AP	1989-02-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-09-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1998-09-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1998-09-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1999-06-16	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0

CDER Filings

ASTELLAS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18116
            [companyName] => ASTELLAS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLOCORT","activeIngredients":"AMCINONIDE","strength":"0.025%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"CYCLOCORT","activeIngredients":"AMCINONIDE","strength":"0.1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CYCLOCORT","submission":"AMCINONIDE","actionType":"0.025%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"CYCLOCORT","submission":"AMCINONIDE","actionType":"0.1%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)