Lamotrigine

Product manufactured by Remedyrepack Inc.

Application Nr Approved Date Route Status External Links
ANDA200672 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Lamotrigine Extended-Release Tablets Are Indicated For: Adjunctive Therapy For Primary Generalized Tonic-Clonic Seizures And Partial-Onset Seizures With Or Without Secondary Generalization In Patients Aged 13 Years And Older. ( 1.1 ) Conversion To Monotherapy In Patients Aged 13 Years And Older With Partial-Onset Seizures Who Are Receiving Treatment With A Single Aed. ( 1.2 ) Limitation Of Use: Safety And Effectiveness In Patients Younger Than 13 Years Have Not Been Established. ( 1.3 ) 1.1 Adjunctive Therapy Lamotrigine Extended-Release Tablets Are Indicated As Adjunctive Therapy For Primary Generalized Tonic-Clonic (Pgtc) Seizures And Partial-Onset Seizures With Or Without Secondary Generalization In Patients Aged 13 Years And Older. 1.2 Monotherapy Lamotrigine Extended-Release Tablets Are Indicated For Conversion To Monotherapy In Patients Aged 13 Years And Older With Partial-Onset Seizures Who Are Receiving Treatment With A Single Antiepileptic Drug (Aed). Safety And Effectiveness Of Lamotrigine Extended-Release Tablets Have Not Been Established (1) As Initial Monotherapy Or (2) For Simultaneous Conversion To Monotherapy From 2 Or More Concomitant Aeds. 1.3 Limitation Of Use Safety And Effectiveness Of Lamotrigine Extended-Release Tablets For Use In Patients Younger Than 13 Years Have Not Been Established.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

Comments