Treats edema associated with congestive heart failure, cirrhosis … the nephrotic syndrome. NDA 18413, held by Chartwell Rx. Furosemide.
As of Nov 13, 2026, NDA 18413 (Furosemide), held by Chartwell Rx, was first approved by FDA on Nov 30, 1983, with 37 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 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 30, 1983 | Original application | Approved | None posted |
| Furosemide20MG · tablet;oral | Furosemide | Discontinued |
| Furosemide40MG · tablet;oral | Furosemide | Discontinued |
| Aug 7, 2015 | Supplement 62Manufacturing | Approved | None posted |
| Jul 11, 2012 | Supplement 60Labeling · Standard review | Approved | None posted |
| Dec 27, 2010 | Supplement 58Labeling | Approved | None posted |
| Mar 12, 2009 | Supplement 54Labeling | Approved | None posted |
| Feb 6, 2009 | Supplement 51Labeling | Approved | None posted |
| Feb 6, 2009 | Supplement 49Labeling | Approved | None posted |
| Oct 24, 2002 | Supplement 38Manufacturing | Approved | None posted |
| Jul 29, 2002 | Supplement 39Manufacturing | Approved | None posted |
| Sep 12, 2001 | Supplement 36Manufacturing | Approved | None posted |
| Apr 14, 2001 | Supplement 35Manufacturing | Approved | None posted |
| Feb 9, 2000 | Supplement 34Labeling | Approved | None posted |
| Feb 9, 2000 | Supplement 32Manufacturing | Approved | None posted |
| Jan 28, 2000 | Supplement 33Manufacturing | Approved | None posted |
| Aug 20, 1999 | Supplement 31Manufacturing | Approved | None posted |
| Jun 8, 1999 | Supplement 29Manufacturing | Approved | None posted |
| Jun 8, 1999 | Supplement 28Manufacturing | Approved | None posted |
| Jun 8, 1999 | Supplement 27Manufacturing | Approved | None posted |
| Jun 8, 1999 | Supplement 26Manufacturing | Approved | None posted |
| Feb 1, 1999 | Supplement 25Manufacturing | Approved | None posted |
| Dec 9, 1998 | Supplement 24Manufacturing | Approved | None posted |
| Apr 30, 1998 | Supplement 23Manufacturing | Approved | None posted |
| May 30, 1997 | Supplement 22Manufacturing | Approved | None posted |
| Oct 27, 1995 | Supplement 19Manufacturing | Approved | None posted |
| Feb 3, 1993 | Supplement 21Manufacturing | Approved | None posted |
| Aug 20, 1992 | Supplement 18Manufacturing | Approved | None posted |
| Aug 20, 1992 | Supplement 17Manufacturing | Approved | None posted |
| Jun 11, 1992 | Supplement 20Labeling | Approved | None posted |
| Jan 7, 1992 | Supplement 16Labeling | Approved | None posted |
| Jun 25, 1991 | Supplement 15Labeling | Approved | None posted |
| Aug 5, 1988 | Supplement 13Labeling | Approved | None posted |
| Apr 25, 1988 | Supplement 12Manufacturing | Approved | None posted |
| Apr 25, 1988 | Supplement 11Manufacturing | Approved | None posted |
| Apr 25, 1988 | Supplement 10Manufacturing | Approved | None posted |
| Oct 15, 1986 | Supplement 5Manufacturing | Approved | None posted |
| Oct 15, 1986 | Supplement 4Manufacturing | Approved | None posted |
| Oct 15, 1986 | Supplement 3Manufacturing | Approved | None posted |
| Oct 15, 1986 | Supplement 2Manufacturing | Approved | None posted |
| Nov 30, 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
