NDA 022460

GLAXOSMITHKLINE

FDA Drug Application

Application #022460

Documents

• Letter: 2010-06-16
• Letter: 2011-06-13
• Letter: 2012-06-29
• Letter: 2013-04-30
• Label: 2010-06-15
• Label: 2011-06-10
• Label: 2012-06-28
• Label: 2013-04-29
• Review: 2011-02-03
• Other Important Information from FDA: 2011-12-20
• Letter: 2010-03-22
• Letter: 2013-04-30
• Letter: 2013-04-30
• Label: 2013-04-29
• Label: 2013-04-29
• Summary Review: 2011-02-03
• Label: 2017-11-03
• Label: 2017-11-03
• Label: 2020-12-28
• Letter: 2021-01-04

Application Sponsors

NDA 022460

GLAXOSMITHKLINE

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

0.5MG;0.4MG

1

JALYN

DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2010-06-14	STANDARD
LABELING; Labeling	SUPPL	2	AP	2012-06-27	UNKNOWN
LABELING; Labeling	SUPPL	3	AP	2013-04-25	UNKNOWN
LABELING; Labeling	SUPPL	4	AP	2013-04-25	UNKNOWN
LABELING; Labeling	SUPPL	5	AP	2013-04-25	STANDARD
LABELING; Labeling	SUPPL	7	AP	2017-11-01	STANDARD
LABELING; Labeling	SUPPL	8	AP	2017-11-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2016-06-13	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-12-28	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	6
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	15
SUPPL	7	Null	15
SUPPL	8	Null	31
SUPPL	9	Null	0
SUPPL	11	Null	33

TE Codes

001

Prescription

AB

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22460
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"JALYN","activeIngredients":"DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE","strength":"0.5MG;0.4MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/01\/2017","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022460s007s008lbl.pdf\"}]","notes":""},{"actionDate":"11\/01\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022460s007s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/25\/2013","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022460s003s004s005lbl.pdf\"}]","notes":""},{"actionDate":"04\/25\/2013","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022460s003s004s005lbl.pdf\"}]","notes":""},{"actionDate":"04\/25\/2013","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022460s003s004s005lbl.pdf\"}]","notes":""},{"actionDate":"06\/27\/2012","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022460s002lbl.pdf\"}]","notes":""},{"actionDate":"06\/09\/2011","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022460s001lbl.pdf\"}]","notes":""},{"actionDate":"06\/14\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022460s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"JALYN","submission":"DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE","actionType":"0.5MG;0.4MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-11-01
        )

)