Application Nr Approved Date Route Status External Links
ANDA040298 2001-12-06 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Extended Phenytoin Sodium Capsules Are Indicated For The Control Of Generalized Tonic-Clonic (grand Mal) And Complex Partial (psychomotor, Temporal Lobe) Seizures And Prevention And Treatment Of Seizures Occurring During Or Following Neurosurgery. Phenytoin Serum Level Determinations May Be Necessary For Optimal Dosage Adjustments (see Dosage And Administration And Clinical Pharmacology).

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. Hydroxyethyl Cellulose HYDROXYETHYL CELLULOSE Unresolved
3. Magnesium Oxide MAGNESIUM OXIDE Molecular DS-Dietary supplement , MISC-Miscellaneous , NUTR-Nutrient GRAS-Generally recognized as safe.
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. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Phenytoin Sodium PHENYTOIN SODIUM ZINC2510358