From USFDA
Unichem Laboratories has received ANDA approval for its Extended Phenytoin Sodium Capsules USP, 100 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Dilantin (Phenytoin Sodium) Capsules, 100 mg, of Viatris Specialty LLC.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. The product will be commercialized from Unichem's Ghaziabad Plant.
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