NDA 019729

ASTELLAS

FDA Drug Application

Application #019729

Documents

• Review: 2001-05-25

Application Sponsors

NDA 019729

ASTELLAS

Marketing Status

• Discontinued: 001

Application Products

001

LOTION;TOPICAL

0.1%

1

CYCLOCORT

AMCINONIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1988-06-13	STANDARD
LABELING; Labeling	SUPPL	2	AP	1988-09-30
LABELING; Labeling	SUPPL	3	AP	1989-02-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1991-11-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-09-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-09-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-01-19	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0

CDER Filings

ASTELLAS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19729
            [companyName] => ASTELLAS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLOCORT","activeIngredients":"AMCINONIDE","strength":"0.1%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CYCLOCORT","submission":"AMCINONIDE","actionType":"0.1%","submissionClassification":"LOTION;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)