NDA 207071

LEO PHARMA AS

FDA Drug Application

Application #207071

Documents

• Label: 2015-08-04
• Letter: 2015-07-31
• Review: 2016-04-13
• Summary Review: 2016-04-13
• Label: 2020-12-01
• Label: 2020-12-01
• Letter: 2020-12-02
• Letter: 2020-12-02

Application Sponsors

NDA 207071

LEO PHARMA AS

Marketing Status

• Prescription: 001

Application Products

001

AEROSOL, FOAM;TOPICAL

15%

1

FINACEA

AZELAIC ACID

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2015-07-29	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-12-01	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-12-01	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	31
SUPPL	4	Null	15

TE Codes

001

Prescription

AB

CDER Filings

LEO PHARMA AS

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(
    [0] => Array
        (
            [ApplNo] => 207071
            [companyName] => LEO PHARMA AS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FINACEA","activeIngredients":"AZELAIC ACID","strength":"15%","dosageForm":"AEROSOL, FOAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/01\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/207071s002s004lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/207071s002s004lbl.pdf\"}]","notes":""},{"actionDate":"07\/29\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207071s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/29\/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\\\/207071s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/207071Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207071Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207071Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/01\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/207071s002s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/207071Orig1s002,s004ltr.pdf\"}]","notes":">"},{"actionDate":"12\/01\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/207071s002s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/207071Orig1s002,s004ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-12-01
        )

)