Topiramate

Product manufactured by Proficient Rx Lp

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 Usp Is Indicated For: • Monotherapy Epilepsy: Initial Monotherapy In Patients ≥ 2 Years Of Age With Partial Onset Or Primary Generalized Tonic-Clonic Seizures ( 1.1 ) • Adjunctive Therapy Epilepsy: 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 With 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 Tablets Usp 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 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 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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