FOSPHENYTOIN SODIUM (ANDA078736) FDA Approval

The FDA has granted approval for the abbreviated new drug application (ANDA) number 078736 covering fosphenytoin sodium injection, marketed by Pharmobedient. The product is listed as an injectable dosage form (product number 001) with the active ingredient fosphenytoin sodium, strength EQ 50 mg phenytoin Na/mL, and is currently marked as discontinued. The original submission (submission 1) received approval on June 8, 2010. Since then, the agency has approved a series of supplemental labeling amendments (submissions 2, 3, 4, 5, 8, 10, 12, 14) with the most recent approvals dated November 28, 2023. All supplemental submissions were classified under the "Labeling" class with standard review priority.