Manages schizophrenia. ANDA 85789, held by Sandoz. Trifluoperazine Hydrochloride.
As of Nov 15, 2026, ANDA 85789 (Trifluoperazine Hydrochloride), held by Sandoz, was first approved by FDA on Nov 20, 1981, with 53 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 5MG BASE · tablet;oral | Trifluoperazine Hydrochloride | Rx |
| Jan 22, 2025 | Supplement 89Labeling · Standard review | Approved | None posted |
| Jan 15, 2025 | Supplement 88Labeling · Standard review | Approved | None posted |
| Jul 26, 2011 | Supplement 77Labeling | Approved | None posted |
| Dec 6, 2010 | Supplement 76Labeling | Approved | None posted |
| Nov 25, 2008 | Supplement 75Labeling | Approved | None posted |
| Dec 16, 2002 | Supplement 71Manufacturing | Approved | None posted |
| Dec 11, 2002 | Supplement 70Manufacturing | Approved | None posted |
| Apr 19, 2002 | Supplement 69Manufacturing | Approved | None posted |
| Jan 10, 2002 | Supplement 67Manufacturing | Approved | None posted |
| Nov 28, 2001 | Supplement 68Labeling | Approved | None posted |
| Aug 22, 2001 | Supplement 65Manufacturing | Approved | None posted |
| May 9, 2001 | Supplement 66Manufacturing | Approved | None posted |
| Jun 15, 1999 | Supplement 62Manufacturing | Approved | None posted |
| Jun 15, 1999 | Supplement 63Manufacturing | Approved | None posted |
| Jun 15, 1999 | Supplement 64Labeling | Approved | None posted |
| May 5, 1999 | Supplement 61Manufacturing | Approved | None posted |
| Jan 27, 1998 | Supplement 58Manufacturing | Approved | None posted |
| Oct 21, 1997 | Supplement 57Manufacturing | Approved | None posted |
| Oct 21, 1997 | Supplement 59Manufacturing | Approved | None posted |
| Oct 21, 1997 | Supplement 60Manufacturing | Approved | None posted |
| Aug 11, 1997 | Supplement 55Manufacturing | Approved | None posted |
| Aug 11, 1997 | Supplement 56Manufacturing | Approved | None posted |
| Nov 2, 1995 | Supplement 54Manufacturing | Approved | None posted |
| Jan 24, 1994 | Supplement 53Manufacturing | Approved | None posted |
| Aug 13, 1992 | Supplement 52Labeling | Approved | None posted |
| Mar 27, 1992 | Supplement 47Manufacturing | Approved | None posted |
| Mar 27, 1992 | Supplement 48Labeling | Approved | None posted |
| Mar 27, 1992 | Supplement 49Manufacturing | Approved | None posted |
| Feb 3, 1992 | Supplement 51Manufacturing | Approved | None posted |
| Sep 15, 1989 | Supplement 91Labeling | Approved | None posted |
| Sep 15, 1989 | Supplement 45Labeling | Approved | None posted |
| Nov 2, 1988 | Supplement 44Labeling | Approved | None posted |
| Jan 21, 1988 | Supplement 38Manufacturing | Approved | None posted |
| Jan 21, 1988 | Supplement 39Manufacturing | Approved | None posted |
| Jan 21, 1988 | Supplement 40Manufacturing | Approved | None posted |
| Jan 21, 1988 | Supplement 41Manufacturing | Approved | None posted |
| Jan 20, 1987 | Supplement 34Manufacturing | Approved | None posted |
| Jan 16, 1986 | Supplement 29Manufacturing | Approved | None posted |
| Jan 16, 1986 | Supplement 30Manufacturing | Approved | None posted |
| Jan 16, 1986 | Supplement 31Manufacturing | 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 |
| Aug 1, 1983 | Supplement 13Manufacturing | Approved | None posted |
| Aug 1, 1983 | Supplement 14Manufacturing | Approved | None posted |
| Aug 1, 1983 | Supplement 16Manufacturing | Approved | None posted |
| Feb 28, 1983 | Supplement 6Manufacturing | Approved | None posted |
| Dec 15, 1982 | Supplement 1Manufacturing | Approved | None posted |
| Dec 9, 1982 | Supplement 10Manufacturing | Approved | None posted |
| Dec 9, 1982 | Supplement 11Manufacturing | Approved | None posted |
| Dec 9, 1982 | Supplement 12Manufacturing | Approved | None posted |
| Jun 4, 1982 | Supplement 3Manufacturing | Approved | None posted |
| Jun 4, 1982 | Supplement 7Manufacturing | 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
