NDA 021844

LEO PHARMA AS

FDA Drug Application

Application #021844

Documents

• Letter: 2010-01-05
• Letter: 2014-07-24
• Label: 2006-10-23
• Label: 2010-01-12
• Label: 2014-07-24
• Letter: 2006-10-23
• Review: 2008-09-05

Application Sponsors

NDA 021844

LEO PHARMA AS

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

0.05%

1

DESONATE

DESONIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2006-10-20	STANDARD
LABELING; Labeling	SUPPL	2	AP	2009-12-29	STANDARD
LABELING; Labeling	SUPPL	8	AP	2014-07-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2015-01-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2016-03-14	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	2	Null	6
SUPPL	8	Null	7
SUPPL	9	Null	0
SUPPL	10	Null	0

TE Codes

001

Prescription

AB

CDER Filings

LEO PHARMA AS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21844
            [companyName] => LEO PHARMA AS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DESONATE","activeIngredients":"DESONIDE","strength":"0.05%","dosageForm":"GEL;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/22\/2014","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021844s008lbl.pdf\"}]","notes":""},{"actionDate":"12\/29\/2009","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021844s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/20\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021844lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DESONATE","submission":"DESONIDE","actionType":"0.05%","submissionClassification":"GEL;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2014-07-22
        )

)