Application Nr Approved Date Route Status External Links
ANDA040621 2006-12-11 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Phenytoin Is Indicated For The Control Of Tonic-Clonic (grand Mal) And Psychomotor (temporal Lobe) Seizures And Prevention And Treatment Of Seizures Occurring During Or Following Neurosurgery. Phenytoin Serum Level Determinations May Be Necessary For Optimal Dosage Adjustments (see Dosage And Administrationand Clinical Pharmacologysections).

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. 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.
2. Fd&c Blue No. 2 FD&C BLUE NO. 2 Molecular DYE-Dye
3. Fd&c Red No. 40 FD&C RED NO. 40 Molecular
4. Fd&c Blue No. 1 FD&C BLUE NO. 1 Molecular DYE-Dye
5. D&c Yellow No. 10 D&C YELLOW NO. 10 Molecular DYE-Dye

Active Ingredients ( 1 Total)

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

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