LEO PHARMA AS FDA Approval NDA 022185

NDA 022185

LEO PHARMA AS

FDA Drug Application

Application #022185

Documents

Letter2012-12-04
Letter2013-11-08
Label2012-12-04
Label2014-07-29
Review2009-04-14
Letter2008-05-15
Letter2009-03-24
Letter2012-10-22
Letter2013-11-08
Letter2014-09-03
Letter2014-07-29
Label2012-10-18
Label2013-11-19
Label2013-11-08
Label2014-09-03
Label2015-11-04
Label2016-06-23
Summary Review2008-07-17
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Label2019-02-19
Label2019-07-29

Application Sponsors

NDA 022185LEO PHARMA AS

Marketing Status

Prescription001
Prescription002

Application Products

001SUSPENSION;TOPICAL0.064%;0.005%1TACLONEXBETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
002SUSPENSION;TOPICAL0.064%;0.005%1TACLONEXBETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2008-05-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2009-03-20N/A
EFFICACY; EfficacySUPPL10AP2012-10-17STANDARD
LABELING; LabelingSUPPL12AP2012-11-30UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2013-06-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2013-11-07STANDARD
LABELING; LabelingSUPPL16AP2013-11-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2014-02-26STANDARD
EFFICACY; EfficacySUPPL18AP2014-08-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL19AP2015-10-29STANDARD
LABELING; LabelingSUPPL20AP2014-07-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL22AP2016-02-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL23AP2016-03-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL24AP2016-06-21N/A
MANUF (CMC); Manufacturing (CMC)SUPPL25AP2017-06-19N/A
EFFICACY; EfficacySUPPL27AP2019-07-25STANDARD

Submissions Property Types

SUPPL10Null7
SUPPL12Null7
SUPPL14Null0
SUPPL15Null0
SUPPL16Null15
SUPPL17Null0
SUPPL18Null6
SUPPL19Null0
SUPPL20Null15
SUPPL22Null0
SUPPL23Null0
SUPPL24Null15
SUPPL25Null15
SUPPL27Null6

TE Codes

001PrescriptionAB

CDER Filings

LEO PHARMA AS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22185
            [companyName] => LEO PHARMA AS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TACLONEX","activeIngredients":"BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE","strength":"0.064%;0.005%","dosageForm":"SUSPENSION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"TACLONEX","activeIngredients":"BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE","strength":"0.064%;0.005%","dosageForm":"SUSPENSION;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/25\/2019","submission":"SUPPL-27","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022185s027lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2017","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022185s025lbl.pdf\"}]","notes":""},{"actionDate":"06\/21\/2016","submission":"SUPPL-24","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022185s024lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/2015","submission":"SUPPL-19","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022185s019lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"08\/29\/2014","submission":"SUPPL-18","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022185s018lbl.pdf\"}]","notes":""},{"actionDate":"07\/28\/2014","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022185s020lbl.pdf\"}]","notes":""},{"actionDate":"11\/07\/2013","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"11\/07\/2013","submission":"SUPPL-15","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"11\/30\/2012","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022185s012lbl.pdf\"}]","notes":""},{"actionDate":"10\/17\/2012","submission":"SUPPL-10","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022185s010lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TACLONEX","submission":"BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE","actionType":"0.064%;0.005%","submissionClassification":"SUSPENSION;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TACLONEX","submission":"BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE","actionType":"0.064%;0.005%","submissionClassification":"SUSPENSION;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-07-25
        )

)
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