NDA 022436

BAUSCH

FDA Drug Application

Application #022436

Documents

• Letter: 2009-08-17
• Letter: 2010-05-17
• Letter: 2014-01-23
• Label: 2010-05-17
• Label: 2014-01-23
• Review: 2010-01-13
• Summary Review: 2010-01-13
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Label: 2019-12-12
• Letter: 2019-12-12
• Pediatric Medical Review: 1900-01-01

Application Sponsors

NDA 022436

BAUSCH

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

5%;1%

1

XERESE

ACYCLOVIR; HYDROCORTISONE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2009-07-31	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2014-01-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2015-11-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2016-04-14	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-12-11	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	4	Null	7
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	10	Null	6

CDER Filings

BAUSCH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22436
            [companyName] => BAUSCH
            [docInserts] => ["",""]
            [products] => [{"drugName":"XERESE","activeIngredients":"ACYCLOVIR; HYDROCORTISONE","strength":"5%;1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/11\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022436s010lbl.pdf\"}]","notes":""},{"actionDate":"12\/11\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022436s010lbl.pdf\"}]","notes":""},{"actionDate":"01\/22\/2014","submission":"SUPPL-4","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022436s004lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2010","submission":"SUPPL-1","supplementCategories":"Labeling-Proprietary Name Change","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022436s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2010","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022436s001lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"XERESE","submission":"ACYCLOVIR; HYDROCORTISONE","actionType":"5%;1%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-12-11
        )

)