FDA Approves ANDA209953 for Ranolazine Extended‑Release Tablets

The U.S. Food and Drug Administration (FDA) announced approval of Abbreviated New Drug Application (ANDA) 209953 for generic Ranolazine tablets. The approved products are oral extended‑release tablets in strengths of 500 mg and 1 g, intended for prescription use as an anti‑anginal therapy. The tablets are manufactured by Ascend Laboratories, LLC and the application was sponsored by ALKEM LABS LTD. The submission, classified as an original (ORIG) standard review, received an approval status (AP) on November 30, 2020. The products are listed under the human prescription drug category with NDC codes 67877‑525‑10, 67877‑525‑38, 67877‑525‑60, 67877‑526‑05, 67877‑526‑38, and 67877‑526‑60.