Treats edema associated with heart failure, renal disease or hepatic disease. ANDA 76894, held by Heritage. Torsemide.
As of Nov 15, 2026, ANDA 76894 (Torsemide), held by Heritage, was first approved by FDA on May 31, 2005, with 6 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 |
|---|---|---|---|
| May 31, 2005 | Original application | Approved |
| May 6, 2013 | Supplement 8Labeling · Standard review | Approved | None posted |
| Sep 28, 2010 | Supplement 7Labeling | Approved | None posted |
| May 9, 2008 | Supplement 3 | Approved | |
| Apr 10, 2008 | Supplement 4 | Approved | |
| Nov 7, 2007 | Supplement 2 | Approved | |
| Oct 3, 2007 | Supplement 1Manufacturing | Approved | |
| May 31, 2005 | Original application | Approved |
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
