FDA Approves HIKMA ANDA062720 for Cephapirin Sodium Injection (Discontinued Products)

The U.S. Food and Drug Administration (FDA) approved application number ANDA062720 submitted by Hikma Pharmaceuticals. The original submission (submission number 1) received an approval status (AP) on July 2, 1987. The approval covers four injectable cephapirin sodium products (product numbers 001‑004). All products are listed with a marketing status of “Discontinued.” The strengths are: 500 mg base per vial (product 001), 1 g base per vial (product 002), 2 g base per vial (product 003), and 20 g base per vial (product 004). Each product is classified as an injection with no reference drug designation and is not a reference standard. No active marketing status or future availability is indicated for these products.