Application Nr Approved Date Route Status External Links
ANDA040765 2008-11-12 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, Usp 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 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. (1)

All Formulated Excipients (3 Total)

Name Structure Kind Function Status
1. Gelatin GELATIN Unresolved
2. Mannitol MANNITOL Molecular 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.

Active Ingredients ( 1 Total)

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

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