ANDA 88561, held by Watson Labs. Thioridazine Hydrochloride.
As of Nov 15, 2026, ANDA 88561 (Thioridazine Hydrochloride), held by Watson Labs, was first approved by FDA on May 11, 1984, with 15 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 Hydrochloride10MG · tablet;oral | Thioridazine Hydrochloride | Discontinued |
| Feb 24, 2017 | Supplement 24Labeling · Standard review | Approved | None posted |
| Nov 3, 2015 | Supplement 23Labeling | Approved | None posted |
| Jan 31, 1997 | Supplement 22Manufacturing | Approved | None posted |
| Feb 4, 1991 | Supplement 21Labeling | Approved | None posted |
| Sep 17, 1990 | Supplement 20Labeling | Approved | None posted |
| Jul 5, 1988 | Supplement 19Labeling | Approved | None posted |
| Apr 22, 1988 | Supplement 18Labeling | Approved | None posted |
| Mar 29, 1988 | Supplement 17Manufacturing | Approved | None posted |
| Dec 10, 1987 | Supplement 16Manufacturing | Approved | None posted |
| May 15, 1987 | Supplement 14Manufacturing | Approved | None posted |
| Nov 26, 1985 | Supplement 9Manufacturing | Approved | None posted |
| Nov 26, 1985 | Supplement 8Manufacturing | Approved | None posted |
| Nov 26, 1985 | Supplement 7Manufacturing | Approved | None posted |
| Oct 8, 1985 | Supplement 5Manufacturing | Approved | None posted |
| Oct 8, 1985 | Supplement 4Manufacturing | 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
