Treats edema. NDA 16092, held by Bausch. Ethacrynic Acid.
As of Nov 13, 2026, NDA 16092 (Edecrin), held by Bausch, was first approved by FDA on Jan 10, 1967, with 31 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE EDECRIN is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. 1. Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. 2. Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema. 3. Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome. 4. Intravenous SODIUM EDECRIN is indicated when a rapid onset of diuresis is desired, e.g.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 10, 1967 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Edecrin25MG · tablet;oral | Ethacrynic Acid | RxReference drug |
| Edecrin50MG · tablet;oral | Ethacrynic Acid | Discontinued |
| Mar 30, 2015 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Feb 9, 2005 | Supplement 42Labeling · Standard review | Approved | |
| Feb 3, 2004 | Supplement 39Labeling · Standard review | Approved | |
| Oct 19, 1999 | Supplement 37Labeling · Standard review | Approved | |
| Aug 14, 1998 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Nov 3, 1997 | Supplement 36Labeling · Standard review | Approved | None posted |
| Jun 24, 1996 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Mar 24, 1995 | Supplement 34Labeling · Standard review | Approved | None posted |
| Sep 26, 1994 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Aug 7, 1991 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Sep 6, 1988 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Aug 15, 1988 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Mar 21, 1986 | Supplement 29Labeling | Approved | None posted |
| Jan 13, 1986 | Supplement 28Labeling | Approved | None posted |
| May 13, 1985 | Supplement 23Labeling | Approved | None posted |
| Aug 28, 1984 | Supplement 27Labeling | Approved | None posted |
| Sep 20, 1983 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| May 19, 1983 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Sep 4, 1981 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Jun 17, 1981 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Feb 19, 1981 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Jan 22, 1981 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Jan 16, 1981 | Supplement 21Labeling | Approved | None posted |
| Nov 14, 1980 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Jan 25, 1980 | Supplement 17Labeling | Approved | None posted |
| Nov 29, 1979 | Supplement 16Labeling | Approved | None posted |
| Jun 21, 1979 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Mar 9, 1979 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1978 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Mar 21, 1977 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Feb 9, 1976 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Jan 10, 1967 | Original applicationNew molecular entity · 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
