Treats edema associated with congestive heart failure, cirrhosis … the nephrotic syndrome. NDA 18569, held by Epic Pharma LLC. Furosemide.
As of Nov 13, 2026, NDA 18569 (Furosemide), held by Epic Pharma LLC, was first approved by FDA on Oct 19, 1981, with 33 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Edema Furosemide is 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 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 |
|---|---|---|---|
| Oct 19, 1981 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Furosemide40MG · tablet;oral | Furosemide | Rx |
| Furosemide20MG · tablet;oral | Furosemide | Rx |
| Furosemide80MG · tablet;oral | Furosemide | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 2, 2026 | Supplement 71Labeling · Standard review | Approved | |
| Dec 22, 2020 | Supplement 66Labeling · Standard review | Approved | |
| Oct 7, 2016 | Supplement 63Labeling · Standard review | Approved | |
| Jun 5, 2015 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Oct 4, 2012 | Supplement 61Labeling · Standard review | Approved | None posted |
| Nov 28, 2007 | Supplement 58Labeling | Approved | None posted |
| Dec 16, 2002 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Apr 19, 2002 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Jun 14, 2001 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Jun 14, 2001 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Nov 20, 2000 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Feb 3, 2000 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| May 5, 1999 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Sep 15, 1997 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Nov 8, 1996 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Feb 8, 1995 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Apr 13, 1994 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Mar 30, 1993 | Supplement 40Labeling | Approved | None posted |
| Jul 24, 1992 | Supplement 39Labeling | Approved | None posted |
| Oct 19, 1989 | Supplement 38Labeling | Approved | None posted |
| May 17, 1989 | Supplement 37Labeling | Approved | None posted |
| Dec 6, 1988 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Dec 6, 1988 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Dec 6, 1988 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Aug 25, 1988 | Supplement 36Labeling | Approved | None posted |
| Nov 17, 1987 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Nov 17, 1987 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Nov 17, 1987 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Nov 17, 1987 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Nov 17, 1987 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Nov 17, 1987 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Feb 26, 1986 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Feb 27, 1985 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Oct 19, 1981 | Original applicationNew formulation or manufacturer · Standard review | 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
