Treats edema associated with congestive heart failure, cirrhosis … the nephrotic syndrome. NDA 18823, held by Hikma. Furosemide.
As of Nov 15, 2026, NDA 18823 (Furosemide), held by Hikma, was first approved by FDA on Nov 10, 1983, with 34 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 |
|---|---|---|---|
| Nov 10, 1983 | Original application | Approved | None posted |
| Furosemide20MG · tablet;oral | Furosemide | Rx |
| Furosemide40MG · tablet;oral | Furosemide | Rx |
| Jul 14, 2017 | Supplement 44Labeling · Standard review | Approved | |
| May 10, 2012 | Supplement 42Labeling | Approved | None posted |
| Jan 26, 2011 | Supplement 40Labeling | Approved | None posted |
| May 4, 2009 | Supplement 39Labeling | Approved | None posted |
| Mar 28, 2007 | Supplement 38Labeling | Approved | None posted |
| Sep 20, 2002 | Supplement 33Manufacturing | Approved | None posted |
| May 23, 2002 | Supplement 32Manufacturing | Approved | None posted |
| Apr 29, 2002 | Supplement 31Manufacturing | Approved | None posted |
| Apr 29, 2002 | Supplement 30Manufacturing | Approved | None posted |
| Apr 29, 2002 | Supplement 29Manufacturing | Approved | None posted |
| Aug 30, 2001 | Supplement 28Manufacturing | Approved | None posted |
| Aug 30, 2001 | Supplement 27Manufacturing | Approved | None posted |
| Sep 10, 1998 | Supplement 26Manufacturing | Approved | None posted |
| Apr 22, 1997 | Supplement 25Labeling | Approved | None posted |
| Aug 28, 1996 | Supplement 24Manufacturing | Approved | None posted |
| Jun 23, 1994 | Supplement 23Labeling | Approved | None posted |
| Aug 28, 1992 | Supplement 22Labeling | Approved | None posted |
| Aug 5, 1991 | Supplement 21Manufacturing | Approved | None posted |
| Aug 5, 1991 | Supplement 20Manufacturing | Approved | None posted |
| Mar 28, 1991 | Supplement 18Manufacturing | Approved | None posted |
| Dec 4, 1990 | Supplement 19Labeling | Approved | None posted |
| Feb 23, 1990 | Supplement 16Manufacturing | Approved | None posted |
| Dec 28, 1989 | Supplement 17Labeling | Approved | None posted |
| May 1, 1989 | Supplement 13Labeling | Approved | None posted |
| Nov 14, 1988 | Supplement 15Manufacturing | Approved | None posted |
| Nov 14, 1988 | Supplement 14Manufacturing | Approved | None posted |
| Mar 29, 1988 | Supplement 11Manufacturing | Approved | None posted |
| Mar 14, 1988 | Supplement 7Manufacturing | Approved | None posted |
| Feb 3, 1988 | Supplement 10Manufacturing | Approved | None posted |
| Feb 3, 1988 | Supplement 9Manufacturing | Approved | None posted |
| Feb 3, 1988 | Supplement 8Manufacturing | Approved | None posted |
| Oct 9, 1987 | Supplement 5Manufacturing | Approved | None posted |
| Jan 14, 1986 | Supplement 2Manufacturing | Approved | None posted |
| Oct 1, 1984 | Supplement 1Manufacturing | Approved | None posted |
| Nov 10, 1983 | 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
