Treats edema associated with heart failure, renal disease or hepatic disease. ANDA 78249, held by Aurobindo Pharma. Torsemide.
As of Nov 15, 2026, ANDA 78249 (Torsemide), held by Aurobindo Pharma, was first approved by FDA on Oct 17, 2007, with 4 approved supplements and 0 published complete response letters.
Torsemide is 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. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 17, 2007 | Original application | Approved | None posted |
| May 4, 2020 | Supplement 9Labeling · Standard review | Approved | None posted |
| Sep 30, 2012 | Supplement 1Manufacturing | Approved | None posted |
| Sep 18, 2012 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 22, 2011 | Supplement 2Labeling | Approved | None posted |
| Oct 17, 2007 | Original application | Approved | None posted |
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
