Manages schizophrenia. ANDA 85786, held by Sandoz. Trifluoperazine Hydrochloride.
As of Nov 15, 2026, ANDA 85786 (Trifluoperazine Hydrochloride), held by Sandoz, was first approved by FDA on Nov 20, 1981, with 57 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE For the management of schizophrenia. Trifluoperazine HCl is effective for the short-term treatment of generalized non-psychotic anxiety. However, trifluoperazine HCl is not the first drug to be used in therapy for most patients with non-psychotic anxiety because certain risks associated with its use are not shared by common alternative treatments (i.e., benzodiazepines).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 20, 1981 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Trifluoperazine HydrochlorideEQ 2MG BASE · tablet;oral | Trifluoperazine Hydrochloride | Rx |
| Jan 22, 2025 | Supplement 93Labeling · Standard review | Approved | None posted |
| Jan 15, 2025 | Supplement 92Labeling · Standard review | Approved | None posted |
| Jul 26, 2011 | Supplement 80Labeling | Approved | None posted |
| Dec 6, 2010 | Supplement 79Labeling | Approved | None posted |
| Nov 25, 2008 | Supplement 78Labeling | Approved | None posted |
| Dec 16, 2002 | Supplement 73Manufacturing | Approved | None posted |
| Sep 26, 2002 | Supplement 72Manufacturing | Approved | None posted |
| Apr 19, 2002 | Supplement 71Manufacturing | Approved | None posted |
| Jan 10, 2002 | Supplement 69Manufacturing | Approved | None posted |
| Nov 28, 2001 | Supplement 70Labeling | Approved | None posted |
| Aug 22, 2001 | Supplement 67Manufacturing | Approved | None posted |
| May 9, 2001 | Supplement 68Manufacturing | Approved | None posted |
| Jun 15, 1999 | Supplement 63Manufacturing | Approved | None posted |
| Jun 15, 1999 | Supplement 64Manufacturing | Approved | None posted |
| Jun 15, 1999 | Supplement 65Labeling | Approved | None posted |
| May 5, 1999 | Supplement 62Manufacturing | Approved | None posted |
| Jan 27, 1998 | Supplement 59Manufacturing | Approved | None posted |
| Oct 21, 1997 | Supplement 58Manufacturing | Approved | None posted |
| Oct 21, 1997 | Supplement 60Manufacturing | Approved | None posted |
| Oct 21, 1997 | Supplement 61Manufacturing | Approved | None posted |
| Aug 11, 1997 | Supplement 56Manufacturing | Approved | None posted |
| Aug 11, 1997 | Supplement 57Manufacturing | Approved | None posted |
| Nov 2, 1995 | Supplement 55Manufacturing | Approved | None posted |
| Jan 24, 1994 | Supplement 54Manufacturing | Approved | None posted |
| Aug 13, 1992 | Supplement 53Labeling | Approved | None posted |
| Mar 27, 1992 | Supplement 51Manufacturing | Approved | None posted |
| Mar 27, 1992 | Supplement 50Labeling | Approved | None posted |
| Mar 27, 1992 | Supplement 49Manufacturing | Approved | None posted |
| Feb 3, 1992 | Supplement 52Manufacturing | Approved | None posted |
| Sep 15, 1989 | Supplement 95Labeling | Approved | None posted |
| Sep 15, 1989 | Supplement 48Labeling | Approved | None posted |
| Nov 2, 1988 | Supplement 94Labeling | Approved | None posted |
| Nov 2, 1988 | Supplement 47Labeling | Approved | None posted |
| Oct 28, 1988 | Supplement 46Manufacturing | Approved | None posted |
| Oct 28, 1988 | Supplement 45Manufacturing | Approved | None posted |
| Jan 21, 1988 | Supplement 42Manufacturing | Approved | None posted |
| Jan 21, 1988 | Supplement 41Manufacturing | Approved | None posted |
| Jan 21, 1988 | Supplement 40Manufacturing | Approved | None posted |
| Jan 21, 1988 | Supplement 39Manufacturing | Approved | None posted |
| Jan 20, 1987 | Supplement 35Manufacturing | Approved | None posted |
| Mar 3, 1986 | Supplement 34Manufacturing | Approved | None posted |
| Jan 16, 1986 | Supplement 32Manufacturing | Approved | None posted |
| Jan 16, 1986 | Supplement 31Manufacturing | Approved | None posted |
| Jan 16, 1986 | Supplement 30Manufacturing | Approved | None posted |
| Apr 9, 1985 | Supplement 26Manufacturing | Approved | None posted |
| Jan 7, 1985 | Supplement 25Manufacturing | Approved | None posted |
| Apr 30, 1984 | Supplement 24Manufacturing | Approved | None posted |
| Jul 29, 1983 | Supplement 16Manufacturing | Approved | None posted |
| Jul 29, 1983 | Supplement 14Manufacturing | Approved | None posted |
| Jul 29, 1983 | Supplement 13Manufacturing | Approved | None posted |
| Feb 28, 1983 | Supplement 5Manufacturing | Approved | None posted |
| Dec 15, 1982 | Supplement 1Manufacturing | Approved | None posted |
| Nov 8, 1982 | Supplement 11Manufacturing | Approved | None posted |
| Nov 8, 1982 | Supplement 10Manufacturing | Approved | None posted |
| Nov 8, 1982 | Supplement 9Manufacturing | Approved | None posted |
| Jun 3, 1982 | Supplement 8Manufacturing | Approved | None posted |
| Jun 3, 1982 | Supplement 6Manufacturing | Approved | None posted |
| Nov 20, 1981 | 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
