Topiramate

Product manufactured by Remedyrepack Inc.

Application Nr Approved Date Route Status External Links
ANDA076343 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Topiramate Tablets Are Indicated For: Epilepsy: Initial Monotherapy In Patients ≥2 Years Of Age With Partial Onset Or Primary Generalized Tonic-Clonic Seizures ( 1.1 ); Adjunctive Therapy For Adults And Pediatric Patients (2 To 16 Years Of Age) With Partial Onset Seizures Or Primary Generalized Tonic-Clonic Seizures, And For Patients ≥2 Years Of Age With Seizures Associated With Lennox-Gastaut Syndrome ( 1.2 ) Prophylaxis Of Migraine In Patients 12 Years Of Age And Older ( 1.3 ) 1.1 Monotherapy Epilepsy Topiramate Tablets Are Indicated As Initial Monotherapy For The Treatment Of Partial-Onset Or Primary Generalized Tonic-Clonic Seizures In Patients 2 Years Of Age And Older. 1.2 Adjunctive Therapy Epilepsy Topiramate Tablets Are Indicated As Adjunctive Therapy For The Treatment Of Partial-Onset Seizures, Primary Generalized Tonic-Clonic Seizures, And Seizures Associated With Lennox-Gastaut Syndrome In Patients 2 Years Of Age And Older. 1.3 Migraine Topiramate Tablets Are Indicated For The Preventive Treatment Of Migraine In Patients 12 Years Of Age And Older.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Topiramate TOPIRAMATE ZINC95616603

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