FDA.reportPublic FDA data

Application 020764

Type
NDA
Sponsor
GLAXOSMITHKLINE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAMICTAL CDLAMOTRIGINETABLET, CHEWABLE;ORAL5MGYesNo
002LAMICTAL CDLAMOTRIGINETABLET, CHEWABLE;ORAL25MGYesYes
003LAMICTAL CDLAMOTRIGINETABLET, CHEWABLE;ORAL100MGNoNo
004LAMICTAL CDLAMOTRIGINETABLET, CHEWABLE;ORAL2MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0526LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0526LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0526LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0526LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0526LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0526LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0526LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0527LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0527LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0527LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0527LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0527LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0527LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0527LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0699LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0699LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0699LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0699LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0699LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0699LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0699LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83763SUPPL 2025-10-15
83740SUPPL 2025-10-14
83739SUPPL 2025-10-14
83738SUPPL 2025-10-14
82113SUPPL 2025-05-01
82112SUPPL 2025-05-01
82046SUPPL 2025-04-29
82045SUPPL 2025-04-29
66968SUPPL2021-04-01
66967SUPPL2021-04-01
66941SUPPL2021-04-01
64914SUPPL2020-10-14
64913SUPPL2020-10-14
64901SUPPL2020-10-14
64558SUPPL2020-09-11
64557SUPPL2020-09-11
64515SUPPL2020-09-04
64471SUPPL2020-09-01
64311SUPPL2020-08-19
60132SUPPL2019-09-26
60131SUPPL2019-09-26
60118SUPPL2019-09-26
59716SUPPL2019-08-15
59708SUPPL2019-08-15
54981SUPPL2018-07-26
54960SUPPL2018-07-24
54845SUPPL2018-07-06
54754SUPPL2018-07-05
13376SUPPL2015-05-21
25746SUPPL2015-05-20
35304SUPPL2015-03-25
25744SUPPL2015-03-25
13373SUPPL2015-03-25
3295SUPPL2015-03-25
3294SUPPL2015-01-07
3290SUPPL2015-01-07
13372SUPPL2015-01-05
13369SUPPL2015-01-05
35305SUPPL2014-06-30
25745SUPPL2014-06-12
3293SUPPL2013-12-26
35300SUPPL2013-12-23
41678SUPPL2013-09-06
35298SUPPL2013-09-06
35297SUPPL2013-09-06
25736SUPPL2013-09-06
25735SUPPL2013-09-06
25733SUPPL2013-09-06
13368SUPPL2013-09-06
13367SUPPL2013-09-06
13365SUPPL2013-09-06
3289SUPPL2013-09-06
3288SUPPL2013-09-06
35303SUPPL2012-08-02
25743SUPPL2012-08-02
25742SUPPL2011-12-02
13375SUPPL2011-12-02
25740SUPPL2011-08-08
13374SUPPL2011-08-05
25741SUPPL2011-06-02
25739SUPPL2010-11-03
25738SUPPL2010-11-03
35302SUPPL2010-10-28
35301SUPPL2010-10-28
13370SUPPL2009-06-07
3291SUPPL2009-05-13
35299SUPPL2009-05-12
13371SUPPL2009-05-12
25737SUPPL2009-05-04
3292SUPPL2009-05-04
41677SUPPL2007-05-29
41676SUPPL2005-12-08
3287SUPPL2004-01-22
13366SUPPL2003-07-08
25734SUPPL2003-07-06
13364SUPPL2003-01-17
35296SUPPL2001-05-25
20922SUPPL1999-06-30
20921ORIG1999-05-20
13363SUPPL1998-12-14
3286SUPPL1998-12-14
13362ORIG1998-08-24
3285ORIG1998-08-24