oxcarbazepine

FDA Drug Profile — Oxcarbazepine, Trileptal, oxcarbazepine

Drug Details

Generic Name
oxcarbazepine
Brand Names
Oxcarbazepine, Trileptal, oxcarbazepine
Application Number
ANDA077747
Sponsor
Advagen Pharma Limited
NDC Codes
16
Dosage Forms
TABLET, FILM COATED, POWDER, TABLET, FOR SUSPENSION, SUSPENSION
Routes
ORAL
Active Ingredients
OXCARBAZEPINE

Indications and Usage

1 INDICATIONS AND USAGE Oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. Oxcarbazepine tablets are indicated for: Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures Pediatrics:-Monotherapy in the treatment of partial-onset seizures in children 4–16 years-Adjunctive therapy in the treatment of partial-onset seizures in children 2–16 years ( 1 )