FDA.reportPublic FDA data

Application 020241

Type
NDA
Sponsor
GLAXOSMITHKLINE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAMICTALLAMOTRIGINETABLET;ORAL100MGYesNo
002LAMICTALLAMOTRIGINETABLET;ORAL150MGYesNo
003LAMICTALLAMOTRIGINETABLET;ORAL200MGYesNo
004LAMICTALLAMOTRIGINETABLET;ORAL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
005LAMICTALLAMOTRIGINETABLET;ORAL25MGYesYes
006LAMICTALLAMOTRIGINETABLET;ORAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0594LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0594LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0594LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0594LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0594LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0594LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0594LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0633LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0633LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0633LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0633LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0633LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0633LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0633LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0642LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0642LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0642LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0642LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0642LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0642LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0642LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0643LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0643LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0643LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0643LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0643LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0643LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0643LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0644LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0644LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0644LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0644LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0644LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0644LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0644LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0817LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0817LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0817LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0817LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0817LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0817LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
0173-0817LAMICTALlamotrigineGlaxoSmithKline LLCNDACurrent
21695-223LAMICTALlamotrigineRebel Distributors CorpNDACurrent
21695-224LAMICTALlamotrigineRebel Distributors CorpNDACurrent
55289-410LAMICTALlamotriginePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-410LAMICTALlamotriginePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-410LAMICTALlamotriginePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-410LAMICTALlamotriginePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-410LAMICTALlamotriginePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-410LAMICTALlamotriginePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-410LAMICTALlamotriginePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-410LAMICTALlamotriginePD-Rx Pharmaceuticals, InNDACurrent
70518-0049LAMICTALlamotrigineREMEDYREPACK INC.NDACurrent
70518-0049LAMICTALlamotrigineREMEDYREPACK INC.NDACurrent
70518-0049LAMICTALlamotrigineREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83762SUPPL 2025-10-15
83737SUPPL 2025-10-14
83736SUPPL 2025-10-14
83735SUPPL 2025-10-14
82111SUPPL 2025-05-01
82110SUPPL 2025-05-01
82043SUPPL 2025-04-29
82042SUPPL 2025-04-29
66966SUPPL2021-04-01
66965SUPPL2021-04-01
66940SUPPL2021-04-01
64912SUPPL2020-10-14
64911SUPPL2020-10-14
64900SUPPL2020-10-14
64561SUPPL2020-09-11
64556SUPPL2020-09-11
64555SUPPL2020-09-11
64514SUPPL2020-09-04
64513SUPPL2020-09-04
64470SUPPL2020-09-01
64310SUPPL2020-08-19
60130SUPPL2019-09-26
60129SUPPL2019-09-26
60117SUPPL2019-09-26
59714SUPPL2019-08-15
59707SUPPL2019-08-15
54979SUPPL2018-07-26
54959SUPPL2018-07-24
54846SUPPL2018-07-06
54753SUPPL2018-07-05
12367SUPPL2015-05-21
24652SUPPL2015-05-20
12366SUPPL2015-03-25
12365SUPPL2015-03-25
2239SUPPL2015-03-25
2237SUPPL2015-03-25
24646SUPPL2015-01-07
24642SUPPL2015-01-07
34421SUPPL2015-01-05
12362SUPPL2015-01-05
34426SUPPL2014-06-30
24651SUPPL2014-06-12
2235SUPPL2013-12-26
34420SUPPL2013-12-23
41228SUPPL2013-09-06
34417SUPPL2013-09-06
24641SUPPL2013-09-06
12361SUPPL2013-09-06
12360SUPPL2013-09-06
12359SUPPL2013-09-06
2234SUPPL2013-09-06
2233SUPPL2013-09-06
2232SUPPL2013-09-06
34425SUPPL2012-08-02
24650SUPPL2012-08-02
34424SUPPL2011-12-02
24649SUPPL2011-12-02
24648SUPPL2011-08-08
34423SUPPL2011-08-05
2238SUPPL2011-06-02
24647SUPPL2010-11-03
2236SUPPL2010-11-03
34422SUPPL2010-10-28
12364SUPPL2010-10-28
34418SUPPL2009-07-08
24643SUPPL2009-05-13
34419SUPPL2009-05-12
12363SUPPL2009-05-12
24645SUPPL2009-05-04
24644SUPPL2009-05-04
41227SUPPL2007-05-29
24638SUPPL2006-09-27
12358SUPPL2006-09-26
34414SUPPL2006-09-25
41226SUPPL2005-12-08
2231SUPPL2004-01-22
34416SUPPL2003-07-08
24639SUPPL2003-07-06
24640SUPPL2003-04-18
34413SUPPL2003-03-06
34415SUPPL2001-05-25
20552SUPPL1999-06-30
41225SUPPL1999-05-20
34412SUPPL1998-12-14
2230SUPPL1998-12-14
24637SUPPL1998-08-24
12357SUPPL1998-08-24
64535SUPPL1900-01-01
63722SUPPL1900-01-01
63721SUPPL1900-01-01
63720SUPPL1900-01-01