lamotrigine Disintegrating Oral Tablet

Brand(s)
Lamictal
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Glaxosmithkline Llc (2015-05-18)
Oldest Current Product
2009-06-05
License(s)
NDA, ANDA
RxNORM
DISINTEGRATING ORAL TABLET\LAMOTRIGINE
FDAOB
ORAL\TABLET, ORALLY DISINTEGRATING\LAMOTRIGINE
SPL Active
ORAL\TABLET, ORALLY DISINTEGRATING\LAMOTRIGINE
SPL Moiety
ORAL\TABLET, ORALLY DISINTEGRATING\LAMOTRIGINE

product(s) by strength(s)

lamotrigine 100 mg disintegrating oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730776LamictalNDAGlaxosmithkline Llc2009-06-05LAMOTRIGINEORALTABLET, ORALLY DISINTEGRATINGNDA022251d7e3572d-56fe-4727-2bb4-013ccca22678

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001151528ANDAGlobal Pharmaceuticals2015-01-09LAMOTRIGINEORALTABLET, ORALLY DISINTEGRATINGANDA200828380bddae-5b31-4965-96de-97711d859d11
2498840486ANDAPar Pharmaceutical Companies, Inc.2013-06-02LAMOTRIGINEORALTABLET, ORALLY DISINTEGRATINGANDA204158003663e5-c0c7-4fc1-a64d-313f2a5b10d2

lamotrigine 200 mg disintegrating oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730777LamictalNDAGlaxosmithkline Llc2009-06-05LAMOTRIGINEORALTABLET, ORALLY DISINTEGRATINGNDA022251d7e3572d-56fe-4727-2bb4-013ccca22678

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001151529ANDAGlobal Pharmaceuticals2015-01-09LAMOTRIGINEORALTABLET, ORALLY DISINTEGRATINGANDA200828380bddae-5b31-4965-96de-97711d859d11
2498840487ANDAPar Pharmaceutical Companies, Inc.2013-06-02LAMOTRIGINEORALTABLET, ORALLY DISINTEGRATINGANDA204158003663e5-c0c7-4fc1-a64d-313f2a5b10d2

lamotrigine 25 mg disintegrating oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730772LamictalNDAGlaxosmithkline Llc2009-06-05LAMOTRIGINEORALTABLET, ORALLY DISINTEGRATINGNDA022251d7e3572d-56fe-4727-2bb4-013ccca22678

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001151526ANDAGlobal Pharmaceuticals2015-01-09LAMOTRIGINEORALTABLET, ORALLY DISINTEGRATINGANDA200828380bddae-5b31-4965-96de-97711d859d11
2498840484ANDAPar Pharmaceutical Companies, Inc.2013-06-02LAMOTRIGINEORALTABLET, ORALLY DISINTEGRATINGANDA204158003663e5-c0c7-4fc1-a64d-313f2a5b10d2
3498840880ANDAPar Pharmaceutical Companies, Inc.2013-06-02LAMOTRIGINEORALTABLET, ORALLY DISINTEGRATINGANDA204158003663e5-c0c7-4fc1-a64d-313f2a5b10d2

lamotrigine 50 mg disintegrating oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730774LamictalNDAGlaxosmithkline Llc2009-06-05LAMOTRIGINEORALTABLET, ORALLY DISINTEGRATINGNDA022251d7e3572d-56fe-4727-2bb4-013ccca22678

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001151527ANDAGlobal Pharmaceuticals2015-01-09LAMOTRIGINEORALTABLET, ORALLY DISINTEGRATINGANDA200828380bddae-5b31-4965-96de-97711d859d11
2498840485ANDAPar Pharmaceutical Companies, Inc.2013-06-02LAMOTRIGINEORALTABLET, ORALLY DISINTEGRATINGANDA204158003663e5-c0c7-4fc1-a64d-313f2a5b10d2
3498840881ANDAPar Pharmaceutical Companies, Inc.2013-06-02LAMOTRIGINEORALTABLET, ORALLY DISINTEGRATINGANDA204158003663e5-c0c7-4fc1-a64d-313f2a5b10d2
4498840882ANDAPar Pharmaceutical Companies, Inc.2013-06-02LAMOTRIGINEORALTABLET, ORALLY DISINTEGRATINGANDA204158003663e5-c0c7-4fc1-a64d-313f2a5b10d2

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1ANDA200828LAMOTRIGINEIMPAX LABORATORIES INC2013-07-15PATENT CHALLENGE [2015-09-28]ANDA200828_001, ANDA200828_002, ANDA200828_003, ANDA200828_004
2ANDA204158LAMOTRIGINEPAR PHARMACEUTICAL INC2015-10-27ANDA204158_001, ANDA204158_002, ANDA204158_003, ANDA204158_004
3NDA022251LAMICTAL ODTGLAXOSMITHKLINE LLC2009-05-08p7919115, SUBSTANCE
p8840925, LAMICTAL IS AN ANTIEPILEPTIC DRUG (AED) INDICATED FOR: EPILEPSY-ADJUNCTIVE THERAPY IN PATIENTS GREATER THAN OR EQUAL TO 2 YEARS OF AGE: (1.1) PARTIAL SEIZURES PRIMARY GENERALIZED TONIC-CLONIC SEIZURES, SUBSTANCE
ADDITION 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]NDA022251_001, NDA022251_002, NDA022251_003, NDA022251_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA200828_001RXLAMOTRIGINE (25MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2013-07-15LAMOTRIGINE
2ANDA200828_002RXLAMOTRIGINE (50MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2013-07-15LAMOTRIGINE
3ANDA200828_003RXLAMOTRIGINE (100MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2013-07-15LAMOTRIGINE
4ANDA200828_004RXLAMOTRIGINE (200MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2013-07-15LAMOTRIGINE
5ANDA204158_001RXLAMOTRIGINE (25MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2015-10-27LAMOTRIGINE
6ANDA204158_002RXLAMOTRIGINE (50MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2015-10-27LAMOTRIGINE
7ANDA204158_003RXLAMOTRIGINE (100MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2015-10-27LAMOTRIGINE
8ANDA204158_004RXLAMOTRIGINE (200MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2015-10-27LAMOTRIGINE
9NDA022251_001RXLAMOTRIGINE (25MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2009-05-08LAMICTAL ODT
10NDA022251_002RXLAMOTRIGINE (50MG)ORALTABLET, ORALLY DISINTEGRATINGTrueAB2009-05-08LAMICTAL ODT
11NDA022251_003RXLAMOTRIGINE (100MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2009-05-08LAMICTAL ODT
12NDA022251_004RXLAMOTRIGINE (200MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2009-05-08LAMICTAL ODT

patent(s)

#idexpiration dateapplication(s)
1p7919115 (view patent)2029-01-04NDA022251
2p8840925 (view patent)2028-07-02NDA022251

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1003663e5-c0c7-4fc1-a64d-313f2a5b10d2 (view SPL)HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use LAMOTRIGINE safely and effectively. See full prescribing information for LAMOTRIGINE.LAMOTRIGINE orally disintegrating tablets, for oral use Initial U.S. Approval: 1994prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.MANUFACTURE2015-10-0710498840484, 498840485, 498840486, 498840487, 498840880, 498840881, 498840882
2380bddae-5b31-4965-96de-97711d859d11 (view SPL)These highlights do not include all the information needed to use lamotrigine orally disintegrating tablets safely and effectively. See full prescribing information for lamotrigine orally disintegrating tablets. LAMOTRIGINE Orally Disintegrating Tablets Initial U.S. Approval: 1994prescriptionHuman PrescriptionGlobal Pharmaceuticals2015-02-021001151526, 001151527, 001151528, 001151529
3d7e3572d-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 Llc2015-05-1824001730772, 001730774, 001730776, 001730777, 001730526, 001730527, 001730594, 001730633, 001730642, 001730643, 001730644, 001730699, 001730778, 001730779, 001730780, 001730817lamotrigine Oral Tablet
lamotrigine Chewable Tablet

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