FDA Approves Teva Generic Carvedilol Tablets (ANDA 076373)

The U.S. Food and Drug Administration (FDA) has approved an abbreviated new drug application (ANDA) numbered 076373 for a generic version of carvedilol, a combined alpha‑ and beta‑adrenergic blocker used in cardiovascular therapy. The approved product is manufactured by Teva Pharmaceuticals USA, Inc. and is listed as a prescription‑only oral tablet. FDA data show four tablet strengths: 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg, each identified with a distinct product number. The agency’s submission history includes several labeling supplements (SUPPL) that have been approved. Submission dates range from 30 Oct 2010 to 2 Mar 2020, and all carry an "AP" (approved) status, indicating that labeling changes were accepted. The product is recorded under the generic name carvedilol, with the brand name also listed as Carvedilol, and is classified pharmacologically as an alpha‑adrenergic blocker and beta‑adrenergic blocker.