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004LAMICTALLAMOTRIGINETABLET;ORAL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo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006LAMICTALLAMOTRIGINETABLET;ORAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020241-001LAMICTALLAMOTRIGINE100MGTABLET / ORALABRLD1994-12-27
N020241-002LAMICTALLAMOTRIGINE150MGTABLET / ORALABRLD1994-12-27
N020241-003LAMICTALLAMOTRIGINE200MGTABLET / ORALABRLD1994-12-27
N020241-004LAMICTALLAMOTRIGINE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1994-12-27
N020241-005LAMICTALLAMOTRIGINE25MGTABLET / ORALABRLD1994-12-27
N020241-006LAMICTALLAMOTRIGINE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1994-12-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N020241-001AB
N020241-002AB
N020241-003AB
N020241-005AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020241-001LAMICTAL100MGTABLET / ORALABRLD1994-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020241-002LAMICTAL150MGTABLET / ORALABRLD1994-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020241-003LAMICTAL200MGTABLET / ORALABRLD1994-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020241-004LAMICTAL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1994-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020241-005LAMICTAL25MGTABLET / ORALABRLD, RS1994-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020241-006LAMICTAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1994-12-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020241-001LAMICTAL100MGTABLET / ORALABRLD1994-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020241-002LAMICTAL150MGTABLET / ORALABRLD1994-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020241-003LAMICTAL200MGTABLET / ORALABRLD1994-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020241-004LAMICTAL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1994-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020241-005LAMICTAL25MGTABLET / ORALABRLD, RS1994-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020241-006LAMICTAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1994-12-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N020241-001LAMICTAL100MGTABLET / ORALABRLD1994-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020241-002LAMICTAL150MGTABLET / ORALABRLD1994-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020241-003LAMICTAL200MGTABLET / ORALABRLD1994-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020241-004LAMICTAL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1994-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020241-005LAMICTAL25MGTABLET / ORALABRLD, RS1994-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020241-006LAMICTAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1994-12-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020241-001LAMICTAL100MGTABLET / ORALABRLD1994-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020241-002LAMICTAL150MGTABLET / ORALABRLD1994-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020241-003LAMICTAL200MGTABLET / ORALABRLD1994-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020241-004LAMICTAL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1994-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020241-005LAMICTAL25MGTABLET / ORALABRLD, RS1994-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020241-006LAMICTAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1994-12-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020241-001LAMICTAL100MGTABLET / ORALABRLD1994-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020241-002LAMICTAL150MGTABLET / ORALABRLD1994-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020241-003LAMICTAL200MGTABLET / ORALABRLD1994-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020241-004LAMICTAL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1994-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020241-005LAMICTAL25MGTABLET / ORALABRLD, RS1994-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020241-006LAMICTAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1994-12-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020241-001LAMICTAL100MGTABLET / ORALABRLD1994-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020241-002LAMICTAL150MGTABLET / ORALABRLD1994-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020241-003LAMICTAL200MGTABLET / ORALABRLD1994-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020241-004LAMICTAL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1994-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020241-005LAMICTAL25MGTABLET / ORALABRLD, RS1994-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020241-006LAMICTAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1994-12-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020241-001LAMICTAL100MGTABLET / ORALABRLD1994-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020241-002LAMICTAL150MGTABLET / ORALABRLD1994-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020241-003LAMICTAL200MGTABLET / ORALABRLD1994-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020241-004LAMICTAL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1994-12-272680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020241-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020241-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020241-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020241-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020241-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020241-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020241-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020241-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020241-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020241-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020241-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020241-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020241-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020241-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020241-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020241-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020241-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020241-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020241-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020241-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020241-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020241-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020241-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020241-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020241-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020241-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020241-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020241-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020241-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020241-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020241-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020241-005AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020241-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020241-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020241-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020241-005AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020241-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020241-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020241-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020241-005AB1d06236e962d9…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LAMICTALLAMOTRIGINEGlaxoSmithKline LLCd7e3572d-56fe-4727-2bb4-013ccca226782025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020241
application number: NDA020241
ndc (product): 0173-0633
ndc (product): 0173-0594
ndc (product): 0173-0817
ndc (product): 0173-0642
ndc (product): 0173-0644
ndc (product): 0173-0643

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 55 matching rows.

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, InNDACurrent
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
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