lamotrigine Chewable Tablet

Brand(s)
Lamictal
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Glaxosmithkline Llc (2015-05-18)
Oldest Current Product
1998-09-03
License(s)
NDA, ANDA
RxNORM
CHEWABLE TABLET\LAMOTRIGINE
FDAOB
ORAL\TABLET, CHEWABLE\LAMOTRIGINE
SPL Active
ORAL\TABLET, CHEWABLE\LAMOTRIGINE
SPL Moiety
ORAL\TABLET, CHEWABLE\LAMOTRIGINE

product(s) by strength(s)

lamotrigine 2 mg chewable tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730699LamictalNDAGlaxosmithkline Llc2000-10-12LAMOTRIGINEORALTABLET, CHEWABLENDA020764d7e3572d-56fe-4727-2bb4-013ccca22678

lamotrigine 25 mg chewable tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730527LamictalNDAGlaxosmithkline Llc1998-09-03LAMOTRIGINEORALTABLET, CHEWABLENDA020764d7e3572d-56fe-4727-2bb4-013ccca22678

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930132ANDATeva Pharmaceuticals Usa Inc2006-06-29LAMOTRIGINEORALTABLET, CHEWABLEANDA07642051819994-9155-474f-bee9-392e356db838
2003786925ANDAMylan Pharmaceuticals Inc.2009-01-26LAMOTRIGINEORALTABLET, CHEWABLEANDA0766308b52a051-d892-464c-9318-4ace5a5b514f
3162520598ANDAActavis Pharma, Inc.2009-07-29LAMOTRIGINEORALTABLET, CHEWABLEANDA07692825bbfc59-b566-1f01-8b30-b03fa3906069
4516724140ANDATaro Pharmaceuticals U.S.A., Inc.2009-02-04LAMOTRIGINEORALTABLET, CHEWABLEANDA079204db61fe47-1987-421f-ab4e-6545ff014090
5551110226ANDADr. Reddy'S Laboratories Ltd2009-01-29LAMOTRIGINEORALTABLET, CHEWABLEANDA076701e1a0da17-d67c-e44f-bd42-33c4009e4cdd
6597460312ANDAJubilant Cadista Pharmaceuticals, Inc.2011-03-20LAMOTRIGINEORALTABLET, CHEWABLEANDA20022024f3f23f-c54b-4f75-a966-108b6c5ef3b7
7658620362ANDAAurobindo Pharma Limited2009-11-04LAMOTRIGINEORALTABLET, CHEWABLEANDA090401e08920c2-04a3-4fb5-acc5-0af3140f82e9
8684620229ANDAGlenmark Generics Inc., Usa2009-02-19LAMOTRIGINEORALTABLET, CHEWABLEANDA07909950fcf452-2d21-493e-a1dd-0c6ea9ac6184

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490710ANDARemedyrepack Inc.2011-09-08LAMOTRIGINEORALTABLET, CHEWABLE000930132ANDA0764208e9e8cb6-d28a-475a-9584-a1dee4899c4f
2680840335ANDAAmerican Health Packaging2011-06-17LAMOTRIGINEORALTABLET, CHEWABLE162520598ANDA076928780fc63a-6aaf-4b27-a053-c593f3838dd4

lamotrigine 5 mg chewable tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730526LamictalNDAGlaxosmithkline Llc1998-09-04LAMOTRIGINEORALTABLET, CHEWABLENDA020764d7e3572d-56fe-4727-2bb4-013ccca22678

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930688ANDATeva Pharmaceuticals Usa Inc2006-08-28LAMOTRIGINEORALTABLET, CHEWABLEANDA07642051819994-9155-474f-bee9-392e356db838
2003786905ANDAMylan Pharmaceuticals Inc.2009-01-26LAMOTRIGINEORALTABLET, CHEWABLEANDA0766308b52a051-d892-464c-9318-4ace5a5b514f
3162520597ANDAActavis Pharma, Inc.2009-07-29LAMOTRIGINEORALTABLET, CHEWABLEANDA07692825bbfc59-b566-1f01-8b30-b03fa3906069
4516724139ANDATaro Pharmaceuticals U.S.A., Inc.2009-02-04LAMOTRIGINEORALTABLET, CHEWABLEANDA079204db61fe47-1987-421f-ab4e-6545ff014090
5551110225ANDADr. Reddy'S Laboratories Ltd2009-01-29LAMOTRIGINEORALTABLET, CHEWABLEANDA076701e1a0da17-d67c-e44f-bd42-33c4009e4cdd
6597460311ANDAJubilant Cadista Pharmaceuticals, Inc.2011-03-20LAMOTRIGINEORALTABLET, CHEWABLEANDA20022024f3f23f-c54b-4f75-a966-108b6c5ef3b7
7658620361ANDAAurobindo Pharma Limited2009-11-04LAMOTRIGINEORALTABLET, CHEWABLEANDA090401e08920c2-04a3-4fb5-acc5-0af3140f82e9
8684620228ANDAGlenmark Generics Inc., Usa2009-02-19LAMOTRIGINEORALTABLET, CHEWABLEANDA07909950fcf452-2d21-493e-a1dd-0c6ea9ac6184

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1681514249ANDACarilion Materials Management2008-08-28LAMOTRIGINEORALTABLET, CHEWABLE000930688ANDA076420a7455849-968d-4d85-8733-1e01701d7942

application(s)

#idtitledeprecatedapplicantapprovedexclusivityapproved drug
1ANDA076420LAMOTRIGINETEVA PHARMACEUTICALS USA INC2006-06-21ANDA076420_001, ANDA076420_002
2ANDA076630LAMOTRIGINEMYLAN PHARMACEUTICALS INC2009-01-22ANDA076630_001, ANDA076630_002
3ANDA076701LAMOTRIGINEDR REDDYS LABORATORIES LTD2009-01-22ANDA076701_001, ANDA076701_002
4ANDA076928LAMOTRIGINEWATSON LABORATORIES INC2009-01-22ANDA076928_001, ANDA076928_002, ANDA076928_003
5ANDA078009LAMOTRIGINEZYDUS PHARMACEUTICALS USA INC2009-01-22ANDA078009_002, ANDA078009_003
6ANDA078409LAMOTRIGINETrueSANDOZ INC2009-01-22ANDA078409_002, ANDA078409_003
7ANDA079099LAMOTRIGINEGLENMARK GENERICS LTD2009-02-19ANDA079099_001, ANDA079099_002
8ANDA079204LAMOTRIGINETARO PHARMACEUTICAL INDUSTRIES LTD2009-02-04ANDA079204_001, ANDA079204_002
9ANDA090401LAMOTRIGINEAUROBINDO PHARMA LTD2009-11-04ANDA090401_002, ANDA090401_003
10ANDA200220LAMOTRIGINEJUBILANT GENERICS LTD2011-02-28ANDA200220_001, ANDA200220_002
11ANDA201168LAMOTRIGINEALEMBIC PHARMACEUTICALS LTD2014-06-12ANDA201168_001, ANDA201168_002
12NDA020764LAMICTAL CDGLAXOSMITHKLINE LLC1998-08-24ADDITION OF PED SAFETY INFORMATION DERIVED FROM A MAINTENANCE TREATMENT STUDY OF BIPOLAR 1 DISORDER TO DELAY THE TIME TO OCCURRENCE OF MOOD EPISODES IN PATIENTS (> THAN OR = TO 13 YRS OF AGE) TREATED FOR ACUTE MOOD EPISODES WITH STANDARD THERAPY [2018-05-18]NDA020764_001, NDA020764_002, NDA020764_003, NDA020764_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076420_001RXLAMOTRIGINE (5MG)ORALTABLET, CHEWABLEFalseAB2006-06-21LAMOTRIGINE
2ANDA076420_002RXLAMOTRIGINE (25MG)ORALTABLET, CHEWABLEFalseAB2006-06-21LAMOTRIGINE
3ANDA076630_001RXLAMOTRIGINE (5MG)ORALTABLET, CHEWABLEFalseAB2009-01-22LAMOTRIGINE
4ANDA076630_002RXLAMOTRIGINE (25MG)ORALTABLET, CHEWABLEFalseAB2009-01-22LAMOTRIGINE
5ANDA076701_001RXLAMOTRIGINE (5MG)ORALTABLET, CHEWABLEFalseAB2009-01-22LAMOTRIGINE
6ANDA076701_002RXLAMOTRIGINE (25MG)ORALTABLET, CHEWABLEFalseAB2009-01-22LAMOTRIGINE
7ANDA076928_001RXLAMOTRIGINE (2MG)ORALTABLET, CHEWABLEFalseAB2009-01-22LAMOTRIGINE
8ANDA076928_002RXLAMOTRIGINE (5MG)ORALTABLET, CHEWABLEFalseAB2009-01-22LAMOTRIGINE
9ANDA076928_003RXLAMOTRIGINE (25MG)ORALTABLET, CHEWABLEFalseAB2009-01-22LAMOTRIGINE
10ANDA078009_002RXLAMOTRIGINE (5MG)ORALTABLET, CHEWABLEFalseAB2009-01-22LAMOTRIGINE
11ANDA078009_003RXLAMOTRIGINE (25MG)ORALTABLET, CHEWABLEFalseAB2009-01-22LAMOTRIGINE
12ANDA078409_002discontinuedLAMOTRIGINE (5MG)ORALTABLET, CHEWABLEFalse2009-01-22LAMOTRIGINE
13ANDA078409_003discontinuedLAMOTRIGINE (25MG)ORALTABLET, CHEWABLEFalse2009-01-22LAMOTRIGINE
14ANDA079099_001RXLAMOTRIGINE (5MG)ORALTABLET, CHEWABLEFalseAB2009-02-19LAMOTRIGINE
15ANDA079099_002RXLAMOTRIGINE (25MG)ORALTABLET, CHEWABLEFalseAB2009-02-19LAMOTRIGINE
16ANDA079204_001RXLAMOTRIGINE (5MG)ORALTABLET, CHEWABLEFalseAB2009-02-04LAMOTRIGINE
17ANDA079204_002RXLAMOTRIGINE (25MG)ORALTABLET, CHEWABLEFalseAB2009-02-04LAMOTRIGINE
18ANDA090401_002RXLAMOTRIGINE (5MG)ORALTABLET, CHEWABLEFalseAB2009-11-04LAMOTRIGINE
19ANDA090401_003RXLAMOTRIGINE (25MG)ORALTABLET, CHEWABLEFalseAB2009-11-04LAMOTRIGINE
20ANDA200220_001RXLAMOTRIGINE (5MG)ORALTABLET, CHEWABLEFalseAB2011-02-28LAMOTRIGINE
21ANDA200220_002RXLAMOTRIGINE (25MG)ORALTABLET, CHEWABLEFalseAB2011-02-28LAMOTRIGINE
22ANDA201168_001RXLAMOTRIGINE (5MG)ORALTABLET, CHEWABLEFalseAB2014-06-12LAMOTRIGINE
23ANDA201168_002RXLAMOTRIGINE (25MG)ORALTABLET, CHEWABLEFalseAB2014-06-12LAMOTRIGINE
24NDA020764_001RXLAMOTRIGINE (5MG)ORALTABLET, CHEWABLEFalseAB1998-08-24LAMICTAL CD
25NDA020764_002RXLAMOTRIGINE (25MG)ORALTABLET, CHEWABLETrueAB1998-08-24LAMICTAL CD
26NDA020764_003discontinuedLAMOTRIGINE (100MG)ORALTABLET, CHEWABLEFalse1998-08-24LAMICTAL CD
27NDA020764_004RXLAMOTRIGINE (2MG)ORALTABLET, CHEWABLEFalseAB2000-09-08LAMICTAL CD

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
124f3f23f-c54b-4f75-a966-108b6c5ef3b7 (view SPL)These highlights do not include all the information needed to use lamotrigine safely and effectively. See full prescribing information for lamotrigine tablets (chewable, dispersible). Lamotrigine Tablets (Chewable, Dispersible) Rx Only Initial U.S. Approval: 1994prescriptionHuman PrescriptionJubilant Cadista Pharmaceuticals, Inc.MANUFACTURE2014-02-038597460311, 597460312
225bbfc59-b566-1f01-8b30-b03fa3906069 (view SPL)These highlights do not include all the information needed to use lamotrigine safely and effectively. See full prescribing information for lamotrigine. Lamotrigine Tablets (Chewable, Dispersible) Initial U.S. Approval: 1994prescriptionHuman PrescriptionActavis Pharma, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2013-02-0113162520597, 162520598
350fcf452-2d21-493e-a1dd-0c6ea9ac6184 (view SPL)These highlights do not include all the information needed to use lamotrigine safely and effectively. See full prescribing information for lamotrigine. LAMOTRIGINE tablets (chewable, dispersible), for oral useInitial U.S. Approval: 1994prescriptionHuman PrescriptionGlenmark Generics Inc., UsaANALYSIS, MANUFACTURE2015-06-1515684620228, 684620229
451819994-9155-474f-bee9-392e356db838 (view SPL)These highlights do not include all the information needed to use LAMOTRIGINE TABLETS (CHEWABLE, DISPERSIBLE) safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS (CHEWABLE, DISPERSIBLE). LAMOTRIGINE tablets (chewable, dispersible) for oral useInitial U.S. Approval: 1994prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-11-1315000930132, 000930688
5780fc63a-6aaf-4b27-a053-c593f3838dd4 (view SPL)These highlights do not include all the information needed to use lamotrigine safely and effectively. See full prescribing information for lamotrigine. Lamotrigine Tablets (Chewable, Dispersible) Initial U.S. Approval: 1994prescriptionHuman PrescriptionAmerican Health PackagingREPACK2013-10-234680840335
68b52a051-d892-464c-9318-4ace5a5b514f (view SPL)These highlights do not include all the information needed to use lamotrigine safely and effectively. See full prescribing information for lamotrigine tablets (chewable, dispersible). Lamotrigine Tablets (chewable, dispersible)Initial U.S. Approval: 1994prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2012-01-116003786905, 003786925
78e9e8cb6-d28a-475a-9584-a1dee4899c4f (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-09-081493490710
8a7455849-968d-4d85-8733-1e01701d7942 (view SPL)These highlights do not include all the information needed to use lamotrigine tablets (chewable, dispersible) safely and effectively. See full prescribing information for lamotrigine tablets (chewable, dispersible). LAMOTRIGINE tablets (chewable, dispersible) for oral use Initial U.S. Approval: 1994prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2014-03-142681514249
9d7e3572d-56fe-4727-2bb4-013ccca22678 (view SPL)These highlights do not include all the information needed to use LAMICTAL safely and effectively. See full prescribing information for LAMICTAL.LAMICTAL (lamotrigine) tablets , for oral useLAMICTAL (lamotrigine) chewable dispersible tablets, for oral useLAMICTAL ODT (lamotrigine) orally disintegrating tablets, for oral useInitial U.S. Approval: 1994prescriptionHuman PrescriptionGlaxosmithkline Llc2015-05-1824001730526, 001730527, 001730699, 001730594, 001730633, 001730642, 001730643, 001730644, 001730772, 001730774, 001730776, 001730777, 001730778, 001730779, 001730780, 001730817lamotrigine Disintegrating Oral Tablet
lamotrigine Oral Tablet
10db61fe47-1987-421f-ab4e-6545ff014090 (view SPL)These highlights do not include all the information needed to use LAMOTRIGINE safely and effectively. See full prescribing information for LAMOTRIGINE. LAMOTRIGINE tablets (chewable, dispersible), for oral use Initial U.S. Approval: 1994prescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2015-04-139516724139, 516724140
11e08920c2-04a3-4fb5-acc5-0af3140f82e9 (view SPL)These highlights do not include all the information needed to use LAMOTRIGINE TABLETS (CHEWABLE, DISPERSIBLE) safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS (CHEWABLE, DISPERSIBLE). LAMOTRIGINE tablets (chewable, dispersible) for oral use Initial U.S. Approval: 1994prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2015-10-0715658620361, 658620362
12e1a0da17-d67c-e44f-bd42-33c4009e4cdd (view SPL)These highlights do not include all the information needed to use lamotrigine safely and effectively. See full prescribing information for lamotrigine. Lamotrigine Tablets (chewable, dispersible) Initial U.S. Approval : 1994prescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2012-02-277551110225, 551110226

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII