ANDA 88134, held by Chartwell Rx. Thioridazine Hydrochloride.
As of Nov 15, 2026, ANDA 88134 (Thioridazine Hydrochloride), held by Chartwell Rx, was first approved by FDA on Aug 30, 1983, with 28 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Thioridazine is indicated for the management of schizophrenic patients who fail to respond adequately to treatment with other antipsychotic drugs. Due to the risk of significant, potentially life threatening, proarrhythmic effects with thioridazine treatment, thioridazine should be used only in patients who have failed to respond adequately to treatment with appropriate courses of other antipsychotic drugs, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 30, 1983 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Thioridazine Hydrochloride50MG · tablet;oral | Thioridazine Hydrochloride | Discontinued |
| Jan 22, 2025 | Supplement 48Labeling · Standard review | Approved | None posted |
| Feb 23, 2017 | Supplement 47Labeling · Standard review | Approved | None posted |
| Apr 19, 2016 | Supplement 46Labeling | Approved | None posted |
| Dec 16, 2002 | Supplement 42Manufacturing | Approved | None posted |
| Sep 5, 2002 | Supplement 41Labeling | Approved | None posted |
| Aug 14, 2001 | Supplement 39Labeling | Approved | None posted |
| Feb 21, 2001 | Supplement 40Manufacturing | Approved | None posted |
| May 5, 1999 | Supplement 37Manufacturing | Approved | None posted |
| Oct 20, 1998 | Supplement 35Labeling | Approved | None posted |
| Oct 20, 1998 | Supplement 34Manufacturing | Approved | None posted |
| Sep 18, 1998 | Supplement 36Manufacturing | Approved | None posted |
| Mar 21, 1995 | Supplement 33Manufacturing | Approved | None posted |
| Jan 9, 1990 | Supplement 32Labeling | Approved | None posted |
| Sep 28, 1989 | Supplement 31Labeling | Approved | None posted |
| Nov 10, 1988 | Supplement 30Manufacturing | Approved | None posted |
| Mar 18, 1987 | Supplement 27Manufacturing | Approved | None posted |
| Nov 13, 1986 | Supplement 21Manufacturing | Approved | None posted |
| Nov 13, 1986 | Supplement 20Manufacturing | Approved | None posted |
| Nov 13, 1986 | Supplement 19Manufacturing | Approved | None posted |
| Aug 29, 1986 | Supplement 23Manufacturing | Approved | None posted |
| Apr 18, 1986 | Supplement 24Manufacturing | Approved | None posted |
| Apr 18, 1986 | Supplement 16Manufacturing | Approved | None posted |
| Oct 23, 1984 | Supplement 15Manufacturing | Approved | None posted |
| Oct 23, 1984 | Supplement 7Manufacturing | Approved | None posted |
| Oct 23, 1984 | Supplement 6Manufacturing | Approved | None posted |
| Oct 23, 1984 | Supplement 5Manufacturing | Approved | None posted |
| Oct 23, 1984 | Supplement 4Manufacturing | Approved | None posted |
| Jun 28, 1984 | Supplement 1Manufacturing | Approved | None posted |
| Aug 30, 1983 | 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
