NDA 16363, held by Sanofi Aventis US. Furosemide.
As of Nov 13, 2026, NDA 16363 (Lasix), held by Sanofi Aventis US, was first approved by FDA on Mar 20, 1968, with 43 approved supplements and 0 published complete response letters.
| Dec 7, 2007 | Supplement 31Efficacy (new indication or use) | Approved | None posted |
| Feb 5, 1981 | Supplement 30Efficacy (new indication or use) | Approved | None posted |
| Mar 20, 1968 | Original applicationNew dosage form · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lasix10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Furosemide | DiscontinuedReference drug |
| Dec 7, 2007 | Supplement 31Efficacy (new indication or use) | Approved | None posted |
| Dec 7, 2007 | Supplement 21Labeling | Approved | None posted |
| Dec 7, 2007 | Supplement 16Labeling | Approved | None posted |
| Jun 24, 1996 | Supplement 58Manufacturing · Priority review | Approved | None posted |
| Mar 6, 1996 | Supplement 56Labeling · Standard review | Approved | None posted |
| Aug 4, 1995 | Supplement 57Manufacturing · Priority review | Approved | None posted |
| May 1, 1995 | Supplement 54Manufacturing · Priority review | Approved | None posted |
| Apr 3, 1995 | Supplement 55Manufacturing · Priority review | Approved | None posted |
| Jan 26, 1995 | Supplement 53Labeling · Standard review | Approved | None posted |
| Jan 26, 1995 | Supplement 48Labeling | Approved | None posted |
| Sep 2, 1993 | Supplement 51Manufacturing · Priority review | Approved | None posted |
| Jul 9, 1993 | Supplement 52Manufacturing · Priority review | Approved | None posted |
| Jul 9, 1993 | Supplement 50Labeling · Standard review | Approved | None posted |
| Jul 7, 1993 | Supplement 49Manufacturing · Priority review | Approved | None posted |
| Nov 13, 1992 | Supplement 47Labeling | Approved | None posted |
| Jan 15, 1992 | Supplement 46Labeling | Approved | None posted |
| Sep 14, 1990 | Supplement 45Labeling | Approved | None posted |
| Aug 10, 1990 | Supplement 42Manufacturing · Priority review | Approved | None posted |
| Mar 15, 1990 | Supplement 43Labeling | Approved | None posted |
| Jan 5, 1990 | Supplement 44Manufacturing · Priority review | Approved | None posted |
| Feb 25, 1988 | Supplement 41Manufacturing · Priority review | Approved | None posted |
| Oct 22, 1987 | Supplement 40Manufacturing · Priority review | Approved | None posted |
| Jun 2, 1986 | Supplement 33Labeling | Approved | None posted |
| Jan 22, 1986 | Supplement 39Manufacturing · Priority review | Approved | None posted |
| Oct 1, 1984 | Supplement 38Manufacturing · Priority review | Approved | None posted |
| Jun 7, 1984 | Supplement 37Manufacturing · Priority review | Approved | None posted |
| Jun 14, 1983 | Supplement 35Labeling | Approved | None posted |
| Oct 22, 1982 | Supplement 36Manufacturing · Priority review | Approved | None posted |
| Jun 4, 1982 | Supplement 34Manufacturing · Priority review | Approved | None posted |
| Aug 28, 1981 | Supplement 32Labeling | Approved | None posted |
| Mar 5, 1981 | Supplement 29Labeling | Approved | None posted |
| Feb 5, 1981 | Supplement 30Efficacy (new indication or use) | Approved | None posted |
| Nov 12, 1979 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Aug 21, 1979 | Supplement 20Manufacturing · Priority review | Approved | None posted |
| Jul 2, 1979 | Supplement 27Labeling | Approved | None posted |
| Jun 25, 1979 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| Feb 22, 1979 | Supplement 25Labeling | Approved | None posted |
| Feb 22, 1979 | Supplement 24Labeling | Approved | None posted |
| Apr 14, 1978 | Supplement 23Labeling | Approved | None posted |
| Apr 14, 1978 | Supplement 22Labeling | Approved | None posted |
| Jun 29, 1976 | Supplement 18Labeling | Approved | None posted |
| Sep 29, 1975 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Mar 20, 1975 | Supplement 2REMS · Priority review | Approved | None posted |
| Mar 20, 1968 | Original applicationNew dosage form · Priority 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
