Topiramate

Product manufactured by Proficient Rx Lp

Application Nr Approved Date Route Status External Links
ANDA079162 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Monotherapy Epilepsy Topiramate Tablets Are Indicated As Initial Monotherapy In Patients 10 Years Of Age And Older With Partial Onset Or Primary Generalized Tonic-Clonic Seizures. Effectiveness Was Demonstrated In A Controlled Trial In Patients With Epilepsy Who Had No More Than 2 Seizures In The 3 Months Prior To Enrollment. Safety And Effectiveness In Patients Who Were Converted To Monotherapy From A Previous Regimen Of Other Anticonvulsant Drugs Have Not Been Established In Controlled Trials. Adjunctive Therapy Epilepsy Topiramate Tablets Are Indicated As Adjunctive Therapy For Adults And Pediatric Patients Ages 2 To 16 Years 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.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

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