FDA Approves ANDA 078126 for Fosphenytoin Sodium Injection (Now Discontinued)

The FDA granted approval for ANDA 078126 covering fosphenytoin sodium injection (product number 001) with an original approval date of August 6, 2007. The product is an injectable formulation containing fosphenytoin sodium equivalent to 50 mg phenytoin per mL. Since the initial approval, the agency has issued a series of labeling supplements (submission numbers 5, 6, 7, 8, 9, 10, 11, 13, 15, and 16) on dates ranging from June 24 2016 to August 1 2022, all classified under the “Labeling” category. These supplements reflect updates to the product’s labeling information. Current records list the marketing status of the fosphenytoin sodium injection as “Discontinued.” The original application documents, including the label and approval letter, are available from the FDA’s website.