Treats edema associated with congestive heart failure, cirrhosis … the nephrotic syndrome. ANDA 78010, held by Ipca Labs Ltd. Furosemide.
As of Nov 13, 2026, ANDA 78010 (Furosemide), held by Ipca Labs Ltd, was first approved by FDA on Sep 18, 2006, with 5 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 is particularly useful when an agent with greater diuretic potential is desired. Hypertension 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 alone.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 18, 2006 | 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 28, 2020 | Supplement 13Labeling · Standard review | Approved | None posted |
| May 28, 2020 | Supplement 18Labeling · Standard review | Approved | None posted |
| Nov 30, 2012 | Supplement 11Labeling · Standard review | Approved | None posted |
| Jan 27, 2011 | Supplement 8Labeling | Approved | None posted |
| Jul 9, 2009 | Supplement 3Labeling | Approved | None posted |
| Sep 18, 2006 | 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
