Treats edema associated with heart failure, renal disease or hepatic disease. ANDA 76346, held by Pliva Pharm Ind. Torsemide.
As of Nov 15, 2026, ANDA 76346 (Torsemide), held by Pliva Pharm Ind, was first approved by FDA on May 30, 2003, with 6 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 30, 2003 | Original application | Approved | None posted |
| May 4, 2020 | Supplement 25Labeling · Standard review | Approved | None posted |
| Dec 12, 2012 | Supplement 20Labeling · Standard review | Approved | None posted |
| Sep 21, 2011 | Supplement 18Labeling | Approved | None posted |
| Oct 19, 2004 | Supplement 6Manufacturing | Approved | None posted |
| Oct 19, 2004 | Supplement 7Labeling | Approved | None posted |
| May 5, 2004 | Supplement 5Labeling | Approved | None posted |
| May 30, 2003 | 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
