FDA Approves ANDA078889 for Metoprolol Succinate Extended‑Release Tablets

The U.S. Food and Drug Administration (FDA) issued approval for Abbreviated New Drug Application (ANDA) number ANDA078889 covering metoprolol succinate tablets in an extended‑release formulation. The approval applies to products marketed by multiple manufacturers, including BluePoint Laboratories, Northstar Rx LLC, Quallent Pharmaceuticals Health LLC, and Dr. Reddy's Laboratories (Limited and Inc.). Two product variants were listed: a 100 mg equivalent tartrate strength (product number 001) and a 200 mg equivalent tartrate strength (product number 002). Both are oral tablets intended for prescription use. The original ANDA submission received approval on 15 August 2012. Subsequent labeling supplements were approved on 27 January 2014, 15 July 2016, and most recently on 26 May 2023, reflecting ongoing updates to the product labeling.