Approvals and New Uses
The original application and every efficacy supplement, newest first; all 26 submissions below| Date | Submission | Status | Documents |
|---|
| Apr 22, 1987 | Original application | Approved | None posted |
Products
1 strengths and forms| Product | Active ingredient | Marketing |
|---|
| Furosemide40MG/5ML · solution;oral | Furosemide | Rx |
All 26 submissions, including labeling and manufacturing supplements
| Date | Submission | Status | Documents |
|---|
| Oct 16, 2026 | Supplement 38Manufacturing | Approved | None posted |
| Nov 5, 2020 | Supplement 35Labeling · Standard review | Approved | None posted |
| Nov 5, 2020 | Supplement 32Labeling · Standard review | Approved | None posted |
| May 11, 2012 | Supplement 29Labeling | Approved | None posted |
| Jan 26, 2011 | Supplement 28Labeling | Approved | None posted |
| May 4, 2009 | Supplement 27Labeling | Approved | None posted |
| Mar 28, 2007 | Supplement 26Labeling | Approved | None posted |
| May 23, 2002 | Supplement 22Manufacturing | Approved | None posted |
| Sep 22, 2000 | Supplement 21Manufacturing | Approved | None posted |
| Sep 22, 2000 | Supplement 20Manufacturing | Approved | None posted |
| Oct 8, 1998 | Supplement 19Manufacturing | Approved | None posted |
| Apr 21, 1997 | Supplement 15Labeling | Approved | None posted |
| Apr 21, 1997 | Supplement 14Manufacturing | Approved | None posted |
| Apr 21, 1997 | Supplement 13Manufacturing | Approved | None posted |
| Apr 21, 1997 | Supplement 12Manufacturing | Approved | None posted |
| Apr 21, 1997 | Supplement 11Manufacturing | Approved | None posted |
| Aug 28, 1996 | Supplement 16Manufacturing | Approved | None posted |
| Jun 24, 1994 | Supplement 10Labeling | Approved | None posted |
| Aug 28, 1992 | Supplement 9Labeling | Approved | None posted |
| Dec 18, 1990 | Supplement 8Labeling | Approved | None posted |
| Dec 28, 1989 | Supplement 7Labeling | Approved | None posted |
| Apr 19, 1989 | Supplement 2Labeling | Approved | None posted |
| Nov 7, 1988 | Supplement 5Manufacturing | Approved | None posted |
| Nov 7, 1988 | Supplement 4Manufacturing | Approved | None posted |
| Jul 13, 1988 | Supplement 1Manufacturing | Approved | None posted |
| Apr 22, 1987 | Original application | Approved | None posted |
Identifiers
- Application
- ANDA 70433
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
