Regulatory UpdatesSep 3, 2026•1 min read

FDA Approves Apotex CILOSTAZOL (ANDA077030)

By the PharmaCountry team

FDA has approved Apotex's oral cilostazol tablets (50 mg and 100 mg) under ANDA 077030, adding a generic phosphodiesterase‑3 inhibitor to the market.

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).

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#CILOSTAZOL #generic drug #FDA approval #Oral Tablet #Apotex #phosphodiesterase inhibitor