NDA 018498

ASTELLAS

FDA Drug Application

Application #018498

Documents

• Letter: 2002-09-03
• Label: 2002-09-03

Application Sponsors

NDA 018498

ASTELLAS

Marketing Status

• Discontinued: 001

Application Products

001

OINTMENT;TOPICAL

0.1%

1

CYCLOCORT

AMCINONIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1981-11-13	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	1991-11-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1995-08-09	STANDARD
LABELING; Labeling	SUPPL	8	AP	2002-09-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1998-09-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-08-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1999-06-16	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0

CDER Filings

ASTELLAS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18498
            [companyName] => ASTELLAS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLOCORT","activeIngredients":"AMCINONIDE","strength":"0.1%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"09\/03\/2002","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/18498s8lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CYCLOCORT","submission":"AMCINONIDE","actionType":"0.1%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2002-09-03
        )

)