Application Nr Approved Date Route Status External Links
ANDA084903 2001-05-24 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Primidone, Used Alone Or Concomitantly With Other Anticonvulsants, Is Indicated In The Control Of Grand Mal, Psychomotor, And Focal Epileptic Seizures. It May Control Grand Mal Seizures Refractory To Other Anticonvulsant Therapy.

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
2. Acacia ACACIA Unresolved EMUL-Emulsifier , STAB-Stabilizer FS-Substances permitted as optional ingredient in a standardized food.
3. Methylcelluloses METHYLCELLULOSES Unresolved
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.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Primidone PRIMIDONE ZINC1979

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