Treats edema associated with congestive heart failure, cirrhosis … the nephrotic syndrome. ANDA 76796, held by Prinston. Furosemide.
As of Nov 14, 2026, ANDA 76796 (Furosemide), held by Prinston, was first approved by FDA on Mar 26, 2004, with 7 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 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 |
|---|---|---|---|
| Mar 26, 2004 | Original application | Approved | None posted |
| Furosemide20MG · tablet;oral | Furosemide | Rx |
| Furosemide40MG · tablet;oral | Furosemide | Rx |
| Furosemide80MG · tablet;oral | Furosemide | Rx |
| May 31, 2020 | Supplement 20Labeling · Standard review | Approved | None posted |
| May 31, 2020 | Supplement 16Labeling · Standard review | Approved | None posted |
| May 9, 2012 | Supplement 11Labeling · Standard review | Approved | None posted |
| Jan 27, 2011 | Supplement 9Labeling | Approved | None posted |
| Feb 20, 2009 | Supplement 5Labeling | Approved | None posted |
| Aug 9, 2007 | Supplement 4Labeling | Approved | None posted |
| May 1, 2006 | Supplement 2Labeling | Approved | None posted |
| Mar 26, 2004 | 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
