FDA.reportPublic FDA data

Application 022115

Type
NDA
Sponsor
GLAXOSMITHKLINE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAMICTAL XRLAMOTRIGINETABLET, EXTENDED RELEASE;ORAL25MGYesNo
002LAMICTAL XRLAMOTRIGINETABLET, EXTENDED RELEASE;ORAL50MGYesYes
003LAMICTAL XRLAMOTRIGINETABLET, EXTENDED RELEASE;ORAL100MGYesNo
004LAMICTAL XRLAMOTRIGINETABLET, EXTENDED RELEASE;ORAL200MGYesYes
005LAMICTAL XRLAMOTRIGINETABLET, EXTENDED RELEASE;ORAL300MGYesNo
006LAMICTAL XRLAMOTRIGINETABLET, EXTENDED RELEASE;ORAL250MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0754LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0754LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0754LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0754LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0754LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0754LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0754LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0755LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0755LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0755LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0755LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0755LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0755LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0755LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0756LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0756LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0756LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0756LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0756LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0756LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0756LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0757LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0757LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0757LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0757LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0757LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0757LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0757LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0758LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0758LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0758LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0758LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0758LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0758LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0758LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0759LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0759LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0759LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0759LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0759LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0759LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0759LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0760LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0760LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0760LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0760LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0760LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0760LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0760LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0761LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0761LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0761LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0761LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0761LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0761LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0761LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0781LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0781LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0781LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0781LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0781LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0781LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0781LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83765SUPPL 2025-10-15
83764SUPPL 2025-10-15
83734SUPPL 2025-10-14
83733SUPPL 2025-10-14
83732SUPPL 2025-10-14
82115SUPPL 2025-05-01
82114SUPPL 2025-05-01
82053SUPPL 2025-04-29
82052SUPPL 2025-04-29
66964SUPPL2021-04-01
66963SUPPL2021-04-01
66943SUPPL2021-04-01
64910SUPPL2020-10-14
64909SUPPL2020-10-14
64903SUPPL2020-10-14
64517SUPPL2020-09-04
64473SUPPL2020-09-01
60136SUPPL2019-09-26
60135SUPPL2019-09-26
60120SUPPL2019-09-26
59720SUPPL2019-08-15
59712SUPPL2019-08-15
54977SUPPL2018-07-26
54961SUPPL2018-07-24
54844SUPPL2018-07-06
54756SUPPL2018-07-05
50608SUPPL2017-12-06
38268SUPPL2015-03-25
29270SUPPL2015-03-25
16970SUPPL2015-03-25
6920SUPPL2015-03-25
16967SUPPL2015-01-08
16964SUPPL2015-01-08
6918SUPPL2015-01-07
6916SUPPL2015-01-07
38271SUPPL2014-06-30
29273SUPPL2014-06-12
6915SUPPL2013-12-26
38265SUPPL2013-12-23
29272SUPPL2012-08-02
16969SUPPL2012-08-02
38270SUPPL2011-12-08
29271SUPPL2011-12-02
6917SUPPL2011-08-08
38269SUPPL2011-08-05
16968SUPPL2011-06-29
6919SUPPL2011-06-27
29269SUPPL2011-04-28
38266SUPPL2011-04-25
38267SUPPL2010-10-26
16966SUPPL2010-10-26
38264SUPPL2010-04-19
29268SUPPL2010-04-19
16965SUPPL2010-04-19
6914SUPPL2010-04-19
42420ORIG2010-02-14
24243ORIG2010-02-14
38263ORIG2009-06-10
6913ORIG2009-06-10
53307SUPPL1900-01-01
53306SUPPL1900-01-01
53305SUPPL1900-01-01
53304ORIG1900-01-01
53303ORIG1900-01-01
53302ORIG1900-01-01