Application Nr Approved Date Route Status External Links
ANDA077802 2007-10-09 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Oxcarbazepine Is Indicated For Use As Monotherapy Or Adjunctive Therapy In The Treatment Of Partial Seizures In Adults And As Monotherapy In The Treatment Of Partial Seizures In Children Aged 4years And Above With Epilepsy, And As Adjunctive Therapy In Children Aged 2 Years And Above With Epilepsy.

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Hypromelloses HYPROMELLOSES Unresolved
3. 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.
4. Meglumine MEGLUMINE Molecular
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Oxcarbazepine OXCARBAZEPINE ZINC4724