FDA Approves Actavis Labs Metoprolol Succinate Extended‑Release Tablets (ANDA 076862)

The U.S. Food and Drug Administration has approved application ANDA 076862 submitted by Actavis Labs FL Inc for metoprolol succinate extended‑release tablets. The approval includes two product listings: - Product 001: a prescription tablet with an equivalent strength of 50 mg metoprolol tartrate, marketed as a prescription drug. - Product 002: a discontinued tablet with an equivalent strength of 25 mg metoprolol tartrate. Both products are oral, extended‑release tablets. The sponsor’s submission record shows multiple filings: an original submission (ORIG) on 2009‑08‑03, labeling supplements (submission numbers 6 and 17) on 2015‑06‑29, and a manufacturing (CMC) supplement (submission number 13) on 2014‑05‑15. All listed submissions have a status of "AP" (approved).