Application Nr Approved Date Route Status External Links
ANDA040684 2006-09-05 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 (11 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
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. Black Ink BLACK INK Unresolved
5. Butylparaben BUTYLPARABEN Molecular
6. Edetate Calcium Disodium EDETATE CALCIUM DISODIUM Molecular
7. Gelatin GELATIN Unresolved
8. Methylparaben METHYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
9. Propylparaben PROPYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
10. 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.
11. Sodium Propionate SODIUM PROPIONATE Molecular MISC-Miscellaneous , PRES-Chemical preservative GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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