Phenytoin

Product manufactured by Remedyrepack Inc.

Application Nr Approved Date Route Status External Links
ANDA200565 2014-04-17 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Phenytoin Chewable Tablets Are Indicated For The Treatment 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 Chewable Tablets Are Indicated For The Treatment Of Generalized Tonic-Clonic (grand Mal) And Complex Partial (psychomotor, Temporal Lobe) Seizures And Prevention And Treatment Of Seizures Occurring During Or Following Neurosurgery. ( 1)

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Compressible Sugar COMPRESSIBLE SUGAR Molecular
2. D&c Yellow No. 10 D&C YELLOW NO. 10 Molecular DYE-Dye
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
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. Saccharin Sodium SACCHARIN SODIUM Molecular

Active Ingredients ( 1 Total)

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

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