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

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020764-001LAMICTAL CDLAMOTRIGINE5MGTABLET, FOR SUSPENSION / ORALABRLD1998-08-24
N020764-002LAMICTAL CDLAMOTRIGINE25MGTABLET, FOR SUSPENSION / ORALABRLD, RS1998-08-24
N020764-003LAMICTAL CDLAMOTRIGINE100MGTABLET, FOR SUSPENSION / ORAL1998-08-24
N020764-004LAMICTAL CDLAMOTRIGINE2MGTABLET, FOR SUSPENSION / ORALABRLD2000-09-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N020764-001AB
N020764-002AB
N020764-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020764-001LAMICTAL CD5MGTABLET, FOR SUSPENSION / ORALABRLD1998-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020764-002LAMICTAL CD25MGTABLET, FOR SUSPENSION / ORALABRLD, RS1998-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020764-003LAMICTAL CD100MGTABLET, FOR SUSPENSION / ORAL1998-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020764-004LAMICTAL CD2MGTABLET, FOR SUSPENSION / ORALABRLD2000-09-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020764-001LAMICTAL CD5MGTABLET, FOR SUSPENSION / ORALABRLD1998-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020764-002LAMICTAL CD25MGTABLET, FOR SUSPENSION / ORALABRLD, RS1998-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020764-003LAMICTAL CD100MGTABLET, FOR SUSPENSION / ORAL1998-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020764-004LAMICTAL CD2MGTABLET, FOR SUSPENSION / ORALABRLD2000-09-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020764-001LAMICTAL CD5MGTABLET, FOR SUSPENSION / ORALABRLD1998-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020764-002LAMICTAL CD25MGTABLET, FOR SUSPENSION / ORALABRLD, RS1998-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020764-003LAMICTAL CD100MGTABLET, FOR SUSPENSION / ORAL1998-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020764-004LAMICTAL CD2MGTABLET, FOR SUSPENSION / ORALABRLD2000-09-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020764-001LAMICTAL CD5MGTABLET, FOR SUSPENSION / ORALABRLD1998-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020764-002LAMICTAL CD25MGTABLET, FOR SUSPENSION / ORALABRLD, RS1998-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020764-003LAMICTAL CD100MGTABLET, FOR SUSPENSION / ORAL1998-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020764-004LAMICTAL CD2MGTABLET, FOR SUSPENSION / ORALABRLD2000-09-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020764-001LAMICTAL CD5MGTABLET, FOR SUSPENSION / ORALABRLD1998-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020764-002LAMICTAL CD25MGTABLET, FOR SUSPENSION / ORALABRLD, RS1998-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020764-003LAMICTAL CD100MGTABLET, FOR SUSPENSION / ORAL1998-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020764-004LAMICTAL CD2MGTABLET, FOR SUSPENSION / ORALABRLD2000-09-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020764-001LAMICTAL CD5MGTABLET, FOR SUSPENSION / ORALABRLD1998-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020764-002LAMICTAL CD25MGTABLET, FOR SUSPENSION / ORALABRLD, RS1998-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020764-003LAMICTAL CD100MGTABLET, FOR SUSPENSION / ORAL1998-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020764-004LAMICTAL CD2MGTABLET, FOR SUSPENSION / ORALABRLD2000-09-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020764-001LAMICTAL CD5MGTABLET, FOR SUSPENSION / ORALABRLD1998-08-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020764-002LAMICTAL CD25MGTABLET, FOR SUSPENSION / ORALABRLD, RS1998-08-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020764-003LAMICTAL CD100MGTABLET, FOR SUSPENSION / ORAL1998-08-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020764-004LAMICTAL CD2MGTABLET, FOR SUSPENSION / ORALABRLD2000-09-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020764-001LAMICTAL CD5MGTABLET, FOR SUSPENSION / ORALABRLD1998-08-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020764-002LAMICTAL CD25MGTABLET, FOR SUSPENSION / ORALABRLD, RS1998-08-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020764-003LAMICTAL CD100MGTABLET, FOR SUSPENSION / ORAL1998-08-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020764-004LAMICTAL CD2MGTABLET, FOR SUSPENSION / ORALABRLD2000-09-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020764-001LAMICTAL CD5MGTABLET, FOR SUSPENSION / ORALABRLD1998-08-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020764-002LAMICTAL CD25MGTABLET, FOR SUSPENSION / ORALABRLD, RS1998-08-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020764-003LAMICTAL CD100MGTABLET, FOR SUSPENSION / ORAL1998-08-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020764-004LAMICTAL CD2MGTABLET, FOR SUSPENSION / ORALABRLD2000-09-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020764-001LAMICTAL CD5MGTABLET, FOR SUSPENSION / ORALABRLD1998-08-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N020764-002LAMICTAL CD25MGTABLET, FOR SUSPENSION / ORALABRLD, RS1998-08-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N020764-003LAMICTAL CD100MGTABLET, FOR SUSPENSION / ORAL1998-08-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N020764-004LAMICTAL CD2MGTABLET, FOR SUSPENSION / ORALABRLD2000-09-08d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020764-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020764-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020764-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020764-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020764-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020764-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020764-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020764-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020764-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020764-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020764-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020764-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020764-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020764-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020764-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020764-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020764-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020764-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020764-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020764-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020764-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020764-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020764-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020764-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020764-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020764-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020764-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020764-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020764-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020764-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020764-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020764-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020764-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020764-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020764-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020764-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020764-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020764-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020764-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020764-001AB18072bd15b7f6…

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): 020764
application number: NDA020764
ndc (product): 0173-0699
ndc (product): 0173-0527
ndc (product): 0173-0526

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

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