Manages schizophrenia. ANDA 85788, held by Sandoz. Trifluoperazine Hydrochloride.
As of Nov 15, 2026, ANDA 85788 (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 10MG BASE · tablet;oral | Trifluoperazine Hydrochloride | Rx |
| Jan 22, 2025 | Supplement 88Labeling · Standard review | Approved | None posted |
| Jan 15, 2025 | Supplement 87Labeling · 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 |
| Sep 26, 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 63Labeling | Approved | None posted |
| Jun 15, 1999 | Supplement 62Manufacturing | Approved | None posted |
| Jun 15, 1999 | Supplement 61Manufacturing | Approved | None posted |
| May 5, 1999 | Supplement 60Manufacturing | Approved | None posted |
| Jan 27, 1998 | Supplement 57Manufacturing | Approved | None posted |
| Oct 21, 1997 | Supplement 59Manufacturing | Approved | None posted |
| Oct 21, 1997 | Supplement 58Manufacturing | Approved | None posted |
| Oct 21, 1997 | Supplement 56Manufacturing | Approved | None posted |
| Aug 11, 1997 | Supplement 55Manufacturing | Approved | None posted |
| Aug 11, 1997 | Supplement 54Manufacturing | Approved | None posted |
| Nov 2, 1995 | Supplement 53Manufacturing | Approved | None posted |
| Jan 24, 1994 | Supplement 52Manufacturing | Approved | None posted |
| Aug 13, 1992 | Supplement 51Labeling | Approved | None posted |
| Mar 27, 1992 | Supplement 50Manufacturing | Approved | None posted |
| Mar 27, 1992 | Supplement 47Labeling | Approved | None posted |
| Mar 27, 1992 | Supplement 46Manufacturing | Approved | None posted |
| Feb 3, 1992 | Supplement 49Manufacturing | Approved | None posted |
| Sep 15, 1989 | Supplement 89Labeling | Approved | None posted |
| Sep 15, 1989 | Supplement 44Labeling | Approved | None posted |
| Nov 2, 1988 | Supplement 43Labeling | Approved | None posted |
| Jan 21, 1988 | Supplement 40Manufacturing | Approved | None posted |
| Jan 21, 1988 | Supplement 39Manufacturing | Approved | None posted |
| Jan 21, 1988 | Supplement 38Manufacturing | Approved | None posted |
| Jan 21, 1988 | Supplement 37Manufacturing | Approved | None posted |
| Jan 20, 1987 | Supplement 33Manufacturing | Approved | None posted |
| Mar 3, 1986 | Supplement 32Manufacturing | Approved | None posted |
| Jan 17, 1986 | Supplement 30Manufacturing | Approved | None posted |
| Jan 17, 1986 | Supplement 29Manufacturing | Approved | None posted |
| Jan 17, 1986 | Supplement 28Manufacturing | Approved | None posted |
| Apr 9, 1985 | Supplement 25Manufacturing | Approved | None posted |
| Apr 30, 1984 | Supplement 24Manufacturing | Approved | None posted |
| Aug 10, 1983 | Supplement 13Manufacturing | Approved | None posted |
| Aug 1, 1983 | Supplement 16Manufacturing | Approved | None posted |
| Aug 1, 1983 | Supplement 14Manufacturing | Approved | None posted |
| Feb 25, 1983 | Supplement 5Manufacturing | Approved | None posted |
| Dec 15, 1982 | Supplement 1Manufacturing | Approved | None posted |
| Oct 29, 1982 | Supplement 12Manufacturing | Approved | None posted |
| Oct 29, 1982 | Supplement 11Manufacturing | Approved | None posted |
| Oct 29, 1982 | Supplement 10Manufacturing | 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
