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.
Unichem Laboratories is an international, integrated, specialty pharmaceutical company.
