ANDA 89953, held by Sun Pharm Industries. Thioridazine Hydrochloride.
As of Nov 15, 2026, ANDA 89953 (Thioridazine Hydrochloride), held by Sun Pharm Industries, was first approved by FDA on Oct 7, 1988, with 15 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Thioridazine hydrochloride tablets are 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 hydrochloride tablets 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 |
|---|---|---|---|
| Oct 7, 1988 | Original application | Approved | None posted |
| Thioridazine Hydrochloride100MG · tablet;oral | Thioridazine Hydrochloride | Discontinued |
| Thioridazine Hydrochloride50MG · tablet;oral | Thioridazine Hydrochloride | Discontinued |
| Thioridazine Hydrochloride25MG · tablet;oral | Thioridazine Hydrochloride | Discontinued |
| Thioridazine Hydrochloride10MG · tablet;oral | Thioridazine Hydrochloride | Discontinued |
| Feb 23, 2017 | Supplement 37Labeling · Standard review | Approved | None posted |
| Dec 3, 2010 | Supplement 33Labeling | Approved | None posted |
| Jun 25, 2002 | Supplement 16Manufacturing | Approved | None posted |
| Sep 19, 2001 | Supplement 14Manufacturing | Approved | None posted |
| Sep 17, 2001 | Supplement 15Manufacturing | Approved | None posted |
| Oct 2, 2000 | Supplement 13Labeling | Approved | None posted |
| Oct 2, 2000 | Supplement 12Manufacturing | Approved | None posted |
| May 16, 2000 | Supplement 11Manufacturing | Approved | None posted |
| May 16, 2000 | Supplement 10Manufacturing | Approved | None posted |
| May 6, 1998 | Supplement 9Manufacturing | Approved | None posted |
| Dec 5, 1997 | Supplement 8Manufacturing | Approved | None posted |
| Feb 24, 1997 | Supplement 7Manufacturing | Approved | None posted |
| Jun 22, 1995 | Supplement 6Manufacturing | Approved | None posted |
| Jan 12, 1994 | Supplement 5Manufacturing | Approved | None posted |
| Feb 1, 1990 | Supplement 2Labeling | Approved | None posted |
| Oct 7, 1988 | 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
