Application Nr Approved Date Route Status External Links
ANDA207382 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Topiramate Extended-Release Capsules Are Indicated For: Epilepsy: Initial Monotherapy In Patients 6 Years Of Age And Older With Partial-Onset Or Primary Generalized Tonic-Clonic Seizures ( 1.1 ); Adjunctive Therapy In Patients 6 Years Of Age And Older With Partial-Onset, Primary Generalized Tonic-Clonic Seizures, Or Seizures Associated With Lennox-Gastaut Syndrome (Lgs) ( 1.2 ) Prophylaxis Of Migraine In Patients 12 Years Of Age And Older ( 1.3 ) 1.1 Monotherapy Epilepsy Topiramate Extended-Release Capsules Are Indicated As Initial Monotherapy For The Treatment Of Partial-Onset Or Primary Generalized Tonic-Clonic Seizures In Patients 6 Years Of Age And Older [See Clinical Studies ( 14.2 )] . 1.2 Adjunctive Therapy Epilepsy Topiramate Extended-Release Capsules 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 6 Years Of Age And Older [See Clinical Studies ( 14.3 )] . 1.3 Migraine Topiramate Extended-Release Capsules Are Indicated For The Prophylaxis Of Migraine Headache In Patients 12 Years Of Age And Older [See Clinical Studies ( 14.4 )].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

Comments