FDA Approves Apotex CILOSTAZOL (ANDA077030)

The U.S. Food and Drug Administration has approved an Abbreviated New Drug Application (ANDA) numbered 077030 for the oral tablet formulation of cilostazol submitted by Apotex Corp. The approval covers two tablet strengths, 50 mg and 100 mg, both marketed under the brand name CILOSTAZOL and intended for prescription use. The product is classified as a phosphodiesterase‑3 inhibitor. The original submission received approval on December 10, 2004, with subsequent labeling supplements approved in 2007, 2008, 2016, and 2020. The product is listed with multiple NDC codes (60505‑2521‑1/3/8 and 60505‑2522‑1/3/8).