NDA 050819

BAUSCH

FDA Drug Application

Application #050819

Documents

• Label: 2010-07-01
• Label: 2010-10-18
• Summary Review: 2009-10-29
• Letter: 2008-10-29
• Letter: 2010-06-29
• Letter: 2010-10-20
• Letter: 2014-03-05
• Letter: 2014-11-26
• Label: 2008-11-07
• Label: 2014-03-04
• Label: 2014-11-26
• Review: 2009-10-29
• Review: 2019-05-15
• Letter: 2020-02-25
• Letter: 2020-02-25
• Label: 2020-02-27
• Label: 2020-02-27
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01

Application Sponsors

NDA 050819

BAUSCH

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	GEL;TOPICAL	2.5%;EQ 1.2% BASE	1	ACANYA	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
002	GEL;TOPICAL	3.75%;EQ 1.2% BASE	1	ONEXTON	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2008-10-23	STANDARD
LABELING; Labeling	SUPPL	2	AP	2010-06-23	STANDARD
LABELING; Labeling	SUPPL	3	AP	2010-10-18	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2012-12-18	STANDARD
LABELING; Labeling	SUPPL	10	AP	2014-02-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2014-03-18	STANDARD
EFFICACY; Efficacy	SUPPL	12	AP	2014-11-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2015-09-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2015-11-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2015-10-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2016-03-25	STANDARD
LABELING; Labeling	SUPPL	23	AP	2020-02-21	STANDARD
LABELING; Labeling	SUPPL	24	AP	2020-02-21	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	6
SUPPL	3	Null	6
SUPPL	9	Null	0
SUPPL	10	Null	6
SUPPL	11	Null	0
SUPPL	12	Null	15
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	23	Null	6
SUPPL	24	Null	6

TE Codes

001

Prescription

AB

CDER Filings

BAUSCH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50819
            [companyName] => BAUSCH
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACANYA","activeIngredients":"BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","strength":"2.5%;EQ 1.2% BASE","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ONEXTON","activeIngredients":"BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","strength":"3.75%;EQ 1.2% BASE","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/21\/2020","submission":"SUPPL-24","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050819s023s024lbl.pdf\"}]","notes":""},{"actionDate":"02\/21\/2020","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050819s023s024lbl.pdf\"}]","notes":""},{"actionDate":"02\/21\/2020","submission":"SUPPL-23","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050819s023s024lbl.pdf\"}]","notes":""},{"actionDate":"02\/21\/2020","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050819s023s024lbl.pdf\"}]","notes":""},{"actionDate":"11\/24\/2014","submission":"SUPPL-12","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050819s012lbl.pdf\"}]","notes":""},{"actionDate":"02\/28\/2014","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050819s010lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2010","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/050819s003lbl.pdf\"}]","notes":""},{"actionDate":"06\/23\/2010","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/050819s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/23\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/050819lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ACANYA","submission":"BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","actionType":"2.5%;EQ 1.2% BASE","submissionClassification":"GEL;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ONEXTON","submission":"BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","actionType":"3.75%;EQ 1.2% BASE","submissionClassification":"GEL;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-02-21
        )

)