FDA Approves Teva Torsemide Generic Tablets (ANDA 076346)

The U.S. Food and Drug Administration has granted approval for an Abbreviated New Drug Application (ANDA) numbered 076346 submitted by Teva Pharmaceuticals USA, Inc. for the loop diuretic torsemide. The approved product is an oral tablet marketed under the brand name TORSEMIDE, available in four strengths – 5 mg, 10 mg, 20 mg, and 100 mg – each designated as prescription‑only. The submission history includes an original filing on 30 May 2003, subsequent manufacturing (CMC) and labeling supplements, with the most recent labeling supplement submitted on 4 May 2020. FDA labeling classifies torsemide as a loop diuretic that increases diuresis at the loop of Henle.