NDA 16774, held by Novartis. Mesoridazine Besylate.
As of Nov 13, 2026, NDA 16774 (Serentil), held by Novartis, was first approved by FDA on Feb 27, 1970, with 46 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 27, 1970 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| SerentilEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Mesoridazine Besylate | Discontinued |
| SerentilEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Mesoridazine Besylate | Discontinued |
| SerentilEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Mesoridazine Besylate | Discontinued |
| SerentilEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Mesoridazine Besylate | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 6, 2001 | Supplement 74Manufacturing · Standard review | Approved | None posted |
| Mar 28, 2001 | Supplement 75Manufacturing · Standard review | Approved | None posted |
| Mar 15, 2001 | Supplement 73Labeling · Standard review | Approved | |
| Sep 6, 2000 | Supplement 72Labeling · Standard review | Approved | None posted |
| Mar 14, 1997 | Supplement 71Manufacturing · Standard review | Approved | None posted |
| Nov 22, 1995 | Supplement 70Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1995 | Supplement 69Manufacturing · Standard review | Approved | None posted |
| Aug 1, 1994 | Supplement 66Manufacturing · Standard review | Approved | None posted |
| Jul 1, 1994 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Nov 30, 1990 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Mar 14, 1990 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Nov 3, 1989 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Aug 15, 1989 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| May 10, 1989 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Aug 20, 1987 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| May 26, 1987 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Apr 23, 1987 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1986 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Mar 24, 1986 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Oct 23, 1985 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| May 8, 1985 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Mar 14, 1984 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Jan 19, 1983 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Nov 5, 1982 | Supplement 43Labeling · Standard review | Approved | None posted |
| Jun 22, 1981 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Mar 24, 1981 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Dec 10, 1980 | Supplement 38Labeling · Standard review | Approved | None posted |
| Mar 7, 1980 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Jan 16, 1980 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1979 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Apr 4, 1979 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Dec 8, 1978 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Jun 12, 1978 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Jan 24, 1978 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Jun 3, 1977 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Jun 3, 1977 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Sep 15, 1976 | Supplement 28Labeling · Standard review | Approved | None posted |
| Aug 3, 1976 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Jul 16, 1976 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| May 25, 1976 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Dec 2, 1975 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Jul 1, 1975 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| May 6, 1975 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Mar 31, 1975 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Jan 30, 1975 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jun 7, 1974 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Feb 27, 1970 | 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
