Oxcarbazepine

Product manufactured by Remedyrepack Inc.

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

1 Indications And Usage Oxcarbazepine Tablets Are 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 Pediatric Patients Aged 4 Years And Above With Epilepsy, And As Adjunctive Therapy In Pediatric Patients Aged 2 Years And Above With Partial Seizures. Oxcarbazepine Tablets Are Indicated For: • Adults: Monotherapy Or Adjunctive Therapy In The Treatment Of Partial Seizures • Pediatrics: - Monotherapy In The Treatment Of Partial Seizures In Children 4 To 16 Years - Adjunctive Therapy In The Treatment Of Partial Seizures In Children 2 To 16 Years ( 1)

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

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