NDA 022115

GLAXOSMITHKLINE LLC

FDA Drug Application

Application #022115

Documents

• Letter: 2009-06-10
• Letter: 2010-04-19
• Letter: 2013-12-26
• Letter: 2015-01-07
• Letter: 2011-08-08
• Letter: 2015-01-07
• Letter: 2011-06-27
• Letter: 2015-03-25
• Label: 2015-01-08
• Label: 2010-04-19
• Label: 2010-10-26
• Label: 2015-01-08
• Label: 2011-06-29
• Label: 2012-08-02
• Label: 2015-03-25
• Summary Review: 2010-02-14
• Letter: 2010-04-19
• Letter: 2011-04-28
• Letter: 2015-03-25
• Letter: 2011-12-02
• Letter: 2012-08-02
• Letter: 2014-06-12
• Label: 2009-06-10
• Label: 2010-04-19
• Label: 2013-12-23
• Label: 2011-04-25
• Label: 2010-10-26
• Label: 2015-03-25
• Label: 2011-08-05
• Label: 2011-12-08
• Label: 2014-06-30
• Review: 2010-02-14
• Review: 2017-12-06
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Label: 2018-07-05
• Letter: 2018-07-06
• Letter: 2018-07-24
• Label: 2018-07-26
• Letter: 2019-08-15
• Label: 2019-08-15
• Letter: 2019-09-26
• Label: 2019-09-26
• Medication Guide: 2019-09-26
• Letter: 2020-09-01
• Label: 2020-09-04
• Letter: 2020-10-14
• Label: 2020-10-14
• Medication Guide: 2020-10-14
• Letter: 2021-04-01
• Label: 2021-04-01
• Medication Guide: 2021-04-01

Application Sponsors

NDA 022115

GLAXOSMITHKLINE LLC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	25MG	1	LAMICTAL XR	LAMOTRIGINE
002	TABLET, EXTENDED RELEASE;ORAL	50MG	1	LAMICTAL XR	LAMOTRIGINE
003	TABLET, EXTENDED RELEASE;ORAL	100MG	1	LAMICTAL XR	LAMOTRIGINE
004	TABLET, EXTENDED RELEASE;ORAL	200MG	1	LAMICTAL XR	LAMOTRIGINE
005	TABLET, EXTENDED RELEASE;ORAL	300MG	1	LAMICTAL XR	LAMOTRIGINE
006	TABLET, EXTENDED RELEASE;ORAL	250MG	1	LAMICTAL XR	LAMOTRIGINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2009-05-29	STANDARD
LABELING; Labeling	SUPPL	3	AP	2013-12-20	UNKNOWN
LABELING; Labeling	SUPPL	4	AP	2014-12-30	UNKNOWN
REMS; REMS	SUPPL	5	AP	2010-04-14	N/A
EFFICACY; Efficacy	SUPPL	6	AP	2011-04-25	STANDARD
REMS; REMS	SUPPL	9	AP	2010-10-24	N/A
LABELING; Labeling	SUPPL	10	AP	2010-10-24	UNKNOWN
LABELING; Labeling	SUPPL	11	AP	2015-03-24	STANDARD
LABELING; Labeling	SUPPL	13	AP	2011-08-04	UNKNOWN
LABELING; Labeling	SUPPL	14	AP	2014-12-30	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2011-06-21	N/A
LABELING; Labeling	SUPPL	16	AP	2011-11-29	UNKNOWN
LABELING; Labeling	SUPPL	17	AP	2012-08-01	UNKNOWN
LABELING; Labeling	SUPPL	18	AP	2015-03-24	STANDARD
LABELING; Labeling	SUPPL	19	AP	2014-06-10	STANDARD
LABELING; Labeling	SUPPL	22	AP	2018-07-23	STANDARD
LABELING; Labeling	SUPPL	23	AP	2018-06-27	STANDARD
LABELING; Labeling	SUPPL	24	AP	2020-10-09	STANDARD
LABELING; Labeling	SUPPL	25	AP	2019-08-14	STANDARD
LABELING; Labeling	SUPPL	26	AP	2019-09-25	STANDARD
LABELING; Labeling	SUPPL	27	AP	2020-08-31	STANDARD
LABELING; Labeling	SUPPL	29	AP	2021-03-31	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	6
SUPPL	6	Null	6
SUPPL	9	Null	6
SUPPL	10	Null	6
SUPPL	11	Null	6
SUPPL	13	Null	6
SUPPL	14	Null	6
SUPPL	15	Null	7
SUPPL	16	Null	15
SUPPL	17	Null	6
SUPPL	18	Null	6
SUPPL	19	Null	6
SUPPL	22	Null	15
SUPPL	23	Null	15
SUPPL	24	Null	6
SUPPL	25	Null	31
SUPPL	26	Null	6
SUPPL	27	Null	6
SUPPL	29	Null	31

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB

CDER Filings

GLAXOSMITHKLINE LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22115
            [companyName] => GLAXOSMITHKLINE LLC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/022115s026lbl.pdf#page=50"]
            [products] => [{"drugName":"LAMICTAL XR","activeIngredients":"LAMOTRIGINE","strength":"25MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"LAMICTAL XR","activeIngredients":"LAMOTRIGINE","strength":"50MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"LAMICTAL XR","activeIngredients":"LAMOTRIGINE","strength":"100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"LAMICTAL XR","activeIngredients":"LAMOTRIGINE","strength":"200MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"LAMICTAL XR","activeIngredients":"LAMOTRIGINE","strength":"300MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"LAMICTAL XR","activeIngredients":"LAMOTRIGINE","strength":"250MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"09\/25\/2019","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022115s026lbl.pdf\"}]","notes":""},{"actionDate":"08\/14\/2019","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022115s025lbl.pdf\"}]","notes":""},{"actionDate":"07\/23\/2018","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022115s022lbl.pdf\"}]","notes":""},{"actionDate":"06\/27\/2018","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022115s017lbl.pdf\"}]","notes":""},{"actionDate":"11\/29\/2011","submission":"SUPPL-16","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022115s016lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2011","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022115s013lbl.pdf\"}]","notes":""},{"actionDate":"06\/21\/2011","submission":"SUPPL-15","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022115s015lbl.pdf\"}]","notes":""},{"actionDate":"04\/25\/2011","submission":"SUPPL-6","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022115s006lbl.pdf\"}]","notes":""},{"actionDate":"04\/25\/2011","submission":"SUPPL-6","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022115s006lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2010","submission":"SUPPL-10","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022115s009s010lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2010","submission":"SUPPL-9","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022115s009s010lbl.pdf\"}]","notes":""},{"actionDate":"04\/14\/2010","submission":"SUPPL-5","supplementCategories":"REMS-Assessment","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022115s001s005lbl.pdf\"}]","notes":""},{"actionDate":"04\/14\/2010","submission":"SUPPL-5","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022115s001s005lbl.pdf\"}]","notes":""},{"actionDate":"04\/14\/2010","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022115s001s005lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"05\/29\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022115lbl.pdf\"}]","notes":""}]
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            [supplements] => 
            [actionDate] => 2019-09-25
        )

)