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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