NDA 021852

LEO PHARMA AS

FDA Drug Application

Application #021852

Documents

• Letter: 2010-04-02
• Letter: 2014-12-30
• Letter: 2014-07-29
• Label: 2015-01-08
• Label: 2014-07-29
• Letter: 2006-01-20
• Letter: 2007-10-04
• Letter: 2012-12-04
• Label: 2006-01-13
• Label: 2007-10-04
• Label: 2010-04-04
• Label: 2012-12-03
• Review: 2008-03-24
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Label: 2018-12-26
• Letter: 2018-12-31

Application Sponsors

NDA 021852

LEO PHARMA AS

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;TOPICAL

0.064%;0.005%

1

TACLONEX

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2006-01-09	STANDARD
LABELING; Labeling	SUPPL	2	AP	2007-09-26	STANDARD
LABELING; Labeling	SUPPL	6	AP	2010-03-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2014-06-12	STANDARD
LABELING; Labeling	SUPPL	12	AP	2012-11-30	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2013-04-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2014-03-13	STANDARD
EFFICACY; Efficacy	SUPPL	15	AP	2014-12-23	STANDARD
LABELING; Labeling	SUPPL	16	AP	2014-07-28	STANDARD
LABELING; Labeling	SUPPL	20	AP	2018-12-21	STANDARD

Submissions Property Types

SUPPL	6	Null	6
SUPPL	10	Null	0
SUPPL	12	Null	6
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	15
SUPPL	16	Null	6
SUPPL	20	Null	7

TE Codes

001

Prescription

AB

CDER Filings

LEO PHARMA AS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21852
            [companyName] => LEO PHARMA AS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TACLONEX","activeIngredients":"BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE","strength":"0.064%;0.005%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/21\/2018","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021852s020lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2014","submission":"SUPPL-15","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021852s015lbl.pdf\"}]","notes":""},{"actionDate":"07\/28\/2014","submission":"SUPPL-16","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021852s016lbl.pdf\"}]","notes":""},{"actionDate":"11\/30\/2012","submission":"SUPPL-12","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021852s012lbl.pdf\"}]","notes":""},{"actionDate":"03\/30\/2010","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021852s006lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2007","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021852s002lbl.pdf\"}]","notes":""},{"actionDate":"01\/09\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021852lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TACLONEX","submission":"BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE","actionType":"0.064%;0.005%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-12-21
        )

)