topiramate
topiramate is listed in the FDA National Drug Code directory with 50 NDC codes, marketed under brand names including topiramate, Topamax, Trokendi XR. Available dosage forms: tablet, film coated, capsule, coated pellets, powder, capsule, extended release, tablet, coated.
Drug Details
- Generic Name
- topiramate
- Brand Names
- topiramate, Topamax, Trokendi XR, TOPIRAMATE
- Application Number
- ANDA078235
- Sponsor
- Advanced Rx of Tennessee, LLC
- NDC Codes
- 50
- Dosage Forms
- TABLET, FILM COATED, CAPSULE, COATED PELLETS, POWDER, CAPSULE, EXTENDED RELEASE, TABLET, COATED
- Routes
- ORAL
- Active Ingredients
- TOPIRAMATE
Indications and Usage
1 INDICATIONS AND USAGE Topiramate extended-release capsules USP are indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1 ); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older ( 1.2 ) Preventive treatment of migraine in patients 12 years of age and older ( 1.3 ) 1.1 Monotherapy Epilepsy Topiramate extended-release capsules USP 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 USP 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 USP are indicated for the preventive treatment of migraine in patients 12 years of age and older [see Clinical Studies ( 14.4 )] .