NDA 020273

LEO PHARMA AS

FDA Drug Application

Application #020273

Documents

• Letter: 1999-07-07
• Letter: 2007-10-04
• Letter: 2015-03-13
• Label: 2007-10-04
• Label: 2015-03-17
• Review: 1999-07-07
• Letter: 2005-05-02
• Label: 2005-05-02
• Review: 2009-01-12

Application Sponsors

NDA 020273

LEO PHARMA AS

Marketing Status

• Discontinued: 001

Application Products

001

OINTMENT;TOPICAL

0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

DOVONEX

CALCIPOTRIENE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1993-12-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1995-07-13	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	1997-03-20	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	1999-07-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1999-03-11	STANDARD
LABELING; Labeling	SUPPL	6	AP	2000-01-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-03-23	STANDARD
LABELING; Labeling	SUPPL	8	AP	2005-04-28	STANDARD
LABELING; Labeling	SUPPL	9	AP	2007-09-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2014-07-03	STANDARD
LABELING; Labeling	SUPPL	13	AP	2015-03-11	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	15

TE Codes

001

Prescription

AB

CDER Filings

LEO PHARMA AS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20273
            [companyName] => LEO PHARMA AS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOVONEX","activeIngredients":"CALCIPOTRIENE","strength":"0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"03\/11\/2015","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020273s013,020554s012lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2007","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020611s007,020554s007,020273s009lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2005","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020273s008lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DOVONEX","submission":"CALCIPOTRIENE","actionType":"0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2015-03-11
        )

)