LEO PHARMA AS FDA Approval NDA 207589

NDA 207589

LEO PHARMA AS

FDA Drug Application

Application #207589

Documents

Letter2015-10-20
Label2015-10-22
Label2016-03-14
Summary Review2016-05-04
Letter2016-03-10
Review2016-05-04
Letter2019-07-31
Letter2019-07-31
Letter2019-07-31
Label2019-08-01
Label2019-08-01
Label2019-08-01
Pediatric Medical Review1900-01-01
Letter2020-10-20
Label2020-10-21
Label2021-08-09
Letter2021-08-10

Application Sponsors

NDA 207589LEO PHARMA AS

Marketing Status

Prescription001

Application Products

001AEROSOL, FOAM;TOPICAL0.064%;0.005%1ENSTILARBETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2015-10-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2016-06-20STANDARD
EFFICACY; EfficacySUPPL5AP2019-07-30PRIORITY
LABELING; LabelingSUPPL6AP2019-07-30STANDARD
LABELING; LabelingSUPPL7AP2019-07-30STANDARD
EFFICACY; EfficacySUPPL10AP2020-10-16STANDARD
LABELING; LabelingSUPPL11AP2021-08-06STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null0
SUPPL5Null6
SUPPL6Null6
SUPPL7Null33
SUPPL10Null15
SUPPL11Null6

CDER Filings

LEO PHARMA AS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207589
            [companyName] => LEO PHARMA AS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENSTILAR","activeIngredients":"BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE","strength":"0.064%;0.005%","dosageForm":"AEROSOL, FOAM;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/06\/2021","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/207589s011lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2020","submission":"SUPPL-10","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/207589s010lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2019","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/207589s005s006s007lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/207589s005s006s007lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2019","submission":"SUPPL-5","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/207589s005s006s007lbl.pdf\"}]","notes":""},{"actionDate":"03\/08\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/207589s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207589s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/16\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207589s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/207589Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207589Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207589Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"08\/06\/2021","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/207589s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/207589Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"10\/16\/2020","submission":"SUPPL-10","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/207589s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/207589Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"07\/30\/2019","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/207589s005s006s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/207589Orig1s005,s006,s007ltr.pdf\"}]","notes":">"},{"actionDate":"07\/30\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/207589s005s006s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/207589Orig1s005,s006,s007ltr.pdf\"}]","notes":">"},{"actionDate":"07\/30\/2019","submission":"SUPPL-5","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/207589s005s006s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/207589Orig1s005,s006,s007ltr.pdf\"}]","notes":">"},{"actionDate":"06\/20\/2016","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/08\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/207589s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/207589Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2021-08-06
        )

)
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