Application Nr Approved Date Route Status External Links
ANDA077783 2010-11-01 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Lamotrigine Tablets, Usp Is Indicated For: Epilepsy—adjunctive Therapy In Patients Aged 2 Years And Older: Partial-Onset Seizures. Primary Generalized Tonic-Clonic Seizures. Generalized Seizures Of Lennox-Gastaut Syndrome. ( 1.1) Epilepsy—monotherapy In Patients Aged 16 Years And Older: Conversion To Monotherapy In Patients With Partial-Onset Seizures Who Are Receiving Treatment With Carbamazepine, Phenytoin, Phenobarbital, Primidone, Or Valproate As The Single Aed. ( 1.1) Bipolar Disorder: Maintenance Treatment Of Bipolar I Disorder To Delay The Time To Occurrence Of Mood Episodes In Patients Treated For Acute Mood Episodes With Standard Therapy. ( 1.2) Limitations Of Use: Treatment Of Acute Manic Or Mixed Episodes Is Not Recommended. Effectiveness Of Lamotrigine In The Acute Treatment Of Mood Episodes Has Not Been Established. 1.1 Epilepsy Adjunctive Therapy Lamotrigine Tablets, Usp Is Indicated As Adjunctive Therapy For The Following Seizure Types In Patients Aged 2 Years And Older: Monotherapy Lamotrigine Tablets, Usp Is Indicated For Conversion To Monotherapy In Adults (aged 16 Years And Older) With Partial-Onset Seizures Who Are Receiving Treatment With Carbamazepine, Phenytoin, Phenobarbital, Primidone, Or Valproate As The Single Antiepileptic Drug (aed). Safety And Effectiveness Of Lamotrigine Tablets, Usp Have Not Been Established (1) As Initial Monotherapy; (2) For Conversion To Monotherapy From Aeds Other Than Carbamazepine, Phenytoin, Phenobarbital, Primidone, Or Valproate; Or (3) For Simultaneous Conversion To Monotherapy From 2 Or More Concomitant Aeds. 1.2 Bipolar Disorder Lamotrigine Tablets, Usp Is Indicated For The Maintenance Treatment Of Bipolar I Disorder To Delay The Time To Occurrence Of Mood Episodes (depression, Mania, Hypomania, Mixed Episodes) In Patients Treated For Acute Mood Episodes With Standard Therapy Lamotrigine Tablets, Usp Is Indicated For The Maintenance Treatment Of Bipolar I Disorder To Delay The Time To Occurrence Of Mood Episodes (depression, Mania, Hypomania, Mixed Episodes) In Patients Treated For Acute Mood Episodes With Standard Therapy [ See Clinical Studies (14.1)]. Limitations Of Use Treatment Of Acute Manic Or Mixed Episodes Is Not Recommended. Effectiveness Of Lamotrigine Tablets, Usp In The Acute Treatment Of Mood Episodes Has Not Been Established.

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
3. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
4. Povidones POVIDONES Unresolved
5. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Lamotrigine LAMOTRIGINE ZINC13156

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