Application Nr Approved Date Route Status External Links
ANDA204309 2015-06-10 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Extended Phenytoin Sodium Capsules Are Indicated For The Treatment Of Tonic-Clonic (grand Mal) And Psychomotor (temporal Lobe) Seizures And Prevention And Treatment Of Seizures Occurring During Or Following Neurosurgery. Extended Phenytoin Sodium Capsule Are Indicated For The Treatment Of Tonic-Clonic (grand Mal) And Psychomotor (temporal Lobe) Seizures And Prevention And Treatment Of Seizures Occurring During Or Following Neurosurgery. (1)

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Magnesium Oxide MAGNESIUM OXIDE Molecular DS-Dietary supplement , MISC-Miscellaneous , NUTR-Nutrient GRAS-Generally recognized as safe.
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. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
6. Potassium Hydroxide POTASSIUM HYDROXIDE Molecular B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.

Active Ingredients ( 1 Total)

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

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