ANDA 88567, held by Watson Labs Teva. Thioridazine Hydrochloride.
As of Nov 15, 2026, ANDA 88567 (Thioridazine Hydrochloride), held by Watson Labs Teva, was first approved by FDA on May 11, 1984, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 11, 1984 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Thioridazine Hydrochloride25MG · tablet;oral | Thioridazine Hydrochloride | Discontinued |
| Feb 24, 2017 | Supplement 25Labeling · Standard review | Approved | None posted |
| Nov 3, 2015 | Supplement 24Labeling | Approved | None posted |
| Jan 31, 1997 | Supplement 23Manufacturing | Approved | None posted |
| Feb 4, 1991 | Supplement 22Labeling | Approved | None posted |
| Sep 17, 1990 | Supplement 21Labeling | Approved | None posted |
| Jul 5, 1988 | Supplement 20Labeling | Approved | None posted |
| Jun 9, 1988 | Supplement 17Manufacturing | Approved | None posted |
| Jun 9, 1988 | Supplement 19Manufacturing | Approved | None posted |
| May 15, 1988 | Supplement 14Manufacturing | Approved | None posted |
| Apr 22, 1988 | Supplement 18Labeling | Approved | None posted |
| Oct 26, 1987 | Supplement 16Manufacturing | Approved | None posted |
| Nov 25, 1985 | Supplement 7Manufacturing | Approved | None posted |
| Nov 25, 1985 | Supplement 9Manufacturing | Approved | None posted |
| Nov 25, 1985 | Supplement 10Manufacturing | Approved | None posted |
| Oct 8, 1985 | Supplement 4Manufacturing | Approved | None posted |
| Oct 8, 1985 | Supplement 5Manufacturing | Approved | None posted |
| May 11, 1984 | 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
