NDA 022204

ALLERGAN

FDA Drug Application

Application #022204

Documents

• Letter: 2009-02-03
• Letter: 2015-07-13
• Label: 2009-02-04
• Letter: 2011-02-04
• Letter: 2012-10-12
• Label: 2011-01-31
• Label: 2012-10-12
• Label: 2015-07-13
• Review: 2010-05-13
• Summary Review: 2010-05-13
• Label: 2017-10-26
• Letter: 2017-10-30

Application Sponsors

NDA 022204

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

GEL;TRANSDERMAL

10% (100MG/PACKET)

1

GELNIQUE

OXYBUTYNIN CHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2009-01-27	STANDARD
LABELING; Labeling	SUPPL	4	AP	2011-01-31	STANDARD
LABELING; Labeling	SUPPL	6	AP	2012-10-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2013-08-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2015-08-04	STANDARD
LABELING; Labeling	SUPPL	9	AP	2015-07-10	STANDARD
LABELING; Labeling	SUPPL	10	AP	2017-10-25	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	4	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	6
SUPPL	10	Null	6

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22204
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"GELNIQUE","activeIngredients":"OXYBUTYNIN CHLORIDE","strength":"10% (100MG\/PACKET)","dosageForm":"GEL;TRANSDERMAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/25\/2017","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022204s010lbl.pdf\"}]","notes":""},{"actionDate":"07\/10\/2015","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022204s009lbl.pdf\"}]","notes":""},{"actionDate":"10\/10\/2012","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022204s006lbl.pdf\"}]","notes":""},{"actionDate":"01\/31\/2011","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022204s004lbl.pdf\"}]","notes":""},{"actionDate":"01\/27\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022204lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"GELNIQUE","submission":"OXYBUTYNIN CHLORIDE","actionType":"10% (100MG\/PACKET)","submissionClassification":"GEL;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-10-25
        )

)