Application Nr Approved Date Route Status External Links
ANDA076575 2009-04-17 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Topiramate Capsules (sprinkle) Are An Antiepileptic (aed) Agent 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) 1.1 Monotherapy Epilepsy Topiramate Capsules (sprinkle) Are Indicated As Initial Monotherapy In Patients 2 Years Of Age And Older With Partial Onset Or Primary Generalized Tonic-Clonic Seizures. 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 [ See Clinical Studies ( 14.1) ]. 1.2 Adjunctive Therapy Epilepsy Topiramate Capsules (sprinkle) 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 [ See Clinical Studies ( 14.2) ].

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Ethylcelluloses ETHYLCELLULOSES Unresolved
2. Gelatin GELATIN Unresolved
3. Povidones POVIDONES Unresolved
4. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
5. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
6. Shellac SHELLAC Unresolved
7. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
8. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

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

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