Treats edema associated with congestive heart failure, cirrhosis … the nephrotic syndrome. ANDA 77293, held by Leading. Furosemide.
As of Nov 13, 2026, ANDA 77293 (Furosemide), held by Leading, was first approved by FDA on Nov 9, 2005, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Edema Furosemide tablets are indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide tablets are particularly useful when an agent with greater diuretic potential is desired. Hypertension Oral Furosemide tablets may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with Furosemide tablets alone.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 9, 2005 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Furosemide20MG · tablet;oral | Furosemide | Rx |
| Furosemide40MG · tablet;oral | Furosemide | Rx |
| Furosemide80MG · tablet;oral | Furosemide | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 12, 2016 | Supplement 4Labeling | Approved | None posted |
| May 12, 2016 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jun 29, 2007 | Supplement 3Labeling | Approved | None posted |
| Nov 9, 2005 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
