FDA.reportPublic FDA data

Application 022251

Type
NDA
Sponsor
GLAXOSMITHKLINE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAMICTAL ODTLAMOTRIGINETABLET, ORALLY DISINTEGRATING;ORAL25MGYesNo
002LAMICTAL ODTLAMOTRIGINETABLET, ORALLY DISINTEGRATING;ORAL50MGYesYes
003LAMICTAL ODTLAMOTRIGINETABLET, ORALLY DISINTEGRATING;ORAL100MGYesNo
004LAMICTAL ODTLAMOTRIGINETABLET, ORALLY DISINTEGRATING;ORAL200MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0772LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0772LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0772LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0772LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0772LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0772LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0772LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0774LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0774LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0774LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0774LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0774LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0774LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0774LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0776LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0776LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0776LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0776LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0776LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0776LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0776LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0777LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0777LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0777LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0777LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0777LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0777LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0777LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0778LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0778LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0778LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0778LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0778LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0778LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0778LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0779LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0779LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0779LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0779LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0779LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0779LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0779LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0780LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0780LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0780LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0780LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0780LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0780LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0780LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83767SUPPL 2025-10-15
83766SUPPL 2025-10-15
83743SUPPL 2025-10-14
83742SUPPL 2025-10-14
83741SUPPL 2025-10-14
82117SUPPL 2025-05-01
82116SUPPL 2025-05-01
82049SUPPL 2025-04-29
82048SUPPL 2025-04-29
66970SUPPL2021-04-01
66969SUPPL2021-04-01
66942SUPPL2021-04-01
64916SUPPL2020-10-14
64915SUPPL2020-10-14
64902SUPPL2020-10-14
64560SUPPL2020-09-11
64559SUPPL2020-09-11
64516SUPPL2020-09-04
64472SUPPL2020-09-01
64313SUPPL2020-08-19
60134SUPPL2019-09-26
60133SUPPL2019-09-26
60119SUPPL2019-09-26
59718SUPPL2019-08-15
59711SUPPL2019-08-15
54984SUPPL2018-07-26
54983SUPPL2018-07-26
54962SUPPL2018-07-24
54843SUPPL2018-07-06
54757SUPPL2018-07-05
17132SUPPL2015-05-21
29454SUPPL2015-05-20
38428SUPPL2015-03-25
17128SUPPL2015-03-25
7096SUPPL2015-03-25
7092SUPPL2015-03-25
29449SUPPL2015-01-07
7093SUPPL2015-01-07
38427SUPPL2015-01-05
17126SUPPL2015-01-05
38429SUPPL2014-06-30
29453SUPPL2014-06-12
29448SUPPL2013-12-26
38425SUPPL2013-12-23
17131SUPPL2012-08-02
7095SUPPL2012-08-02
29452SUPPL2011-12-02
17130SUPPL2011-12-02
7094SUPPL2011-08-08
17129SUPPL2011-08-05
29451SUPPL2011-06-02
29450SUPPL2010-11-03
7091SUPPL2010-11-03
38426SUPPL2010-10-28
17127SUPPL2010-10-28
44715ORIG2010-05-27
42466ORIG2010-05-27
17125ORIG2009-07-08
29447ORIG2009-05-13
51220SUPPL1900-01-01
51219SUPPL1900-01-01
51218SUPPL1900-01-01