NDA 021470

LEO PHARMA AS

FDA Drug Application

Application #021470

Documents

• Letter: 2004-06-04
• Letter: 2005-05-17
• Letter: 2015-04-06
• Label: 2010-10-25
• Label: 2013-01-07
• Label: 2015-04-07
• Label: 2016-01-11
• Review: 2004-03-24
• Letter: 2010-11-03
• Letter: 2012-12-21
• Letter: 2016-01-11
• Label: 2002-12-24
• Label: 2005-05-17
• Letter: 2016-08-05
• Label: 2016-08-05
• Label: 2020-11-30
• Label: 2020-11-30
• Letter: 2020-12-01
• Letter: 2020-12-01
• Letter: 2021-11-02
• Label: 2021-11-02

Application Sponsors

NDA 021470

LEO PHARMA AS

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

15%

1

FINACEA

AZELAIC ACID

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2002-12-24	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2005-05-05	STANDARD
LABELING; Labeling	SUPPL	5	AP	2010-10-25	STANDARD
LABELING; Labeling	SUPPL	7	AP	2012-12-18	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2014-10-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2015-02-03	STANDARD
LABELING; Labeling	SUPPL	10	AP	2015-04-03	STANDARD
LABELING; Labeling	SUPPL	12	AP	2015-12-28	STANDARD
LABELING; Labeling	SUPPL	13	AP	2016-08-05	STANDARD
LABELING; Labeling	SUPPL	15	AP	2020-11-27	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-11-27	STANDARD
LABELING; Labeling	SUPPL	17	AP	2021-11-01	STANDARD

Submissions Property Types

SUPPL	3	Null	9
SUPPL	5	Null	7
SUPPL	7	Null	7
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	15
SUPPL	12	Null	31
SUPPL	13	Null	7
SUPPL	15	Null	7
SUPPL	16	Null	31
SUPPL	17	Null	15

TE Codes

001

Prescription

AB

CDER Filings

LEO PHARMA AS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21470
            [companyName] => LEO PHARMA AS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FINACEA","activeIngredients":"AZELAIC ACID","strength":"15%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/01\/2021","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021470s017lbl.pdf\"}]","notes":""},{"actionDate":"11\/01\/2021","submission":"SUPPL-17","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021470s017lbl.pdf\"}]","notes":""},{"actionDate":"11\/27\/2020","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021470s015s016lbl.pdf\"}]","notes":""},{"actionDate":"11\/27\/2020","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021470s015s016lbl.pdf\"}]","notes":""},{"actionDate":"08\/05\/2016","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021470s013lbl.pdf\"}]","notes":""},{"actionDate":"12\/28\/2015","submission":"SUPPL-12","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021470s012lbl.pdf\"}]","notes":""},{"actionDate":"04\/03\/2015","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021470s010lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2012","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021470s007lbl.pdf\"}]","notes":""},{"actionDate":"10\/25\/2010","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021470s005lbl.pdf\"}]","notes":""},{"actionDate":"05\/05\/2005","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021470s003lbl.pdf\"}]","notes":""},{"actionDate":"12\/24\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/021470lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FINACEA","submission":"AZELAIC ACID","actionType":"15%","submissionClassification":"GEL;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2021-11-01
        )

)