Topiramate

Product manufactured by Remedyrepack Inc.

Application Nr Approved Date Route Status External Links
ANDA090278 2009-03-27 Oral RX 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 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 (6 Total)

Name Structure Kind Function Status
1. Anhydrous Lactose ANHYDROUS LACTOSE Molecular
2. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
3. Sodium Starch Glycolate Type A Potato SODIUM STARCH GLYCOLATE TYPE A POTATO Unresolved
4. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
5. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
6. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

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

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