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Treats edema associated with heart failure, renal disease or hepatic disease. ANDA 79234, held by Hetero Labs Ltd Iii. Torsemide.
As of Nov 15, 2026, ANDA 79234 (Torsemide), held by Hetero Labs Ltd Iii, was first approved by FDA on Jan 27, 2009, with 2 approved supplements and 0 published complete response letters.
First approved: Jan 27, 2009
Supplements approved: 2
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Torsemide tablets are a loop diuretic indicated for:
the treatment of edema associated with heart failure, renal disease or hepatic disease.
the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. 1.1 Edema Torsemide tablets are indicated for the treatment of edema associated with heart failure, renal disease or hepatic disease. 1.2 Hypertension Torsemide tablets are indicated for the treatment of hypertension, to lower blood pressure.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
