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 Extended Phenytoin Sodium Capsules, Usp Are Indicated For The Control 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 Serum Level Determinations May Be Necessary For Optimal Dosage Adjustments (see Dosage And Administration And Clinical Pharmacology Sections).

All Formulated Excipients (4 Total)

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