NDA 020554

LEO PHARMA AS

FDA Drug Application

Application #020554

Documents

• Letter: 2007-10-04
• Letter: 2015-03-13
• Letter: 2005-05-02
• Label: 2005-05-02
• Label: 2007-10-04
• Label: 2015-03-17

Application Sponsors

NDA 020554

LEO PHARMA AS

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.005%

1

DOVONEX

CALCIPOTRIENE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1996-07-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-03-11	STANDARD
LABELING; Labeling	SUPPL	4	AP	2000-01-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2001-03-23	STANDARD
LABELING; Labeling	SUPPL	6	AP	2005-04-28	STANDARD
LABELING; Labeling	SUPPL	7	AP	2007-09-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2014-06-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2014-01-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2013-11-21	STANDARD
LABELING; Labeling	SUPPL	12	AP	2015-03-11	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	6

TE Codes

001

Prescription

AB

CDER Filings

LEO PHARMA AS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20554
            [companyName] => LEO PHARMA AS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOVONEX","activeIngredients":"CALCIPOTRIENE","strength":"0.005%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/11\/2015","submission":"SUPPL-12","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-7","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-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020554s006lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DOVONEX","submission":"CALCIPOTRIENE","actionType":"0.005%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2015-03-11
        )

)