NDA 203567

BAUSCH

FDA Drug Application

Application #203567

Documents

• Label: 2014-06-10
• Label: 2015-03-20
• Summary Review: 2014-07-03
• Letter: 2014-06-10
• Letter: 2015-03-02
• Review: 2014-07-02
• Label: 2016-09-27
• Letter: 2016-10-12
• Letter: 2020-04-27
• Label: 2020-04-27
• Letter: 2022-04-04
• Label: 2022-04-05

Application Sponsors

NDA 203567

BAUSCH

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;TOPICAL

10%

1

JUBLIA

EFINACONAZOLE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2014-06-06	STANDARD
LABELING; Labeling	SUPPL	2	AP	2015-02-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2015-08-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2015-11-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2016-04-01	STANDARD
LABELING; Labeling	SUPPL	6	AP	2016-09-22	STANDARD
EFFICACY; Efficacy	SUPPL	9	AP	2020-04-26	STANDARD
LABELING; Labeling	SUPPL	10	AP	2022-03-31	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	7
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	15
SUPPL	9	Null	6
SUPPL	10	Null	7

TE Codes

001

Prescription

AT

CDER Filings

BAUSCH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203567
            [companyName] => BAUSCH
            [docInserts] => ["",""]
            [products] => [{"drugName":"JUBLIA","activeIngredients":"EFINACONAZOLE","strength":"10%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/26\/2020","submission":"SUPPL-9","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/203567s009lbl.pdf\"}]","notes":""},{"actionDate":"09\/22\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203567s006lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203567s002lbl.pdf\"}]","notes":""},{"actionDate":"06\/06\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203567s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/06\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203567s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203567Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/203567_jublia_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/203567Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"04\/26\/2020","submission":"SUPPL-9","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/203567s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/203567Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"09\/22\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203567s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203567Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"04\/01\/2016","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/05\/2015","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/26\/2015","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/27\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203567s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203567Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-04-26
        )

)