Application Nr Approved Date Route Status External Links
ANDA078235 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

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

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

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