ANDA 88563, held by Watson Labs. Thioridazine Hydrochloride.
As of Nov 15, 2026, ANDA 88563 (Thioridazine Hydrochloride), held by Watson Labs, was first approved by FDA on May 11, 1984, with 17 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 Hydrochloride50MG · tablet;oral | Thioridazine Hydrochloride | Discontinued |
| Feb 24, 2017 | Supplement 29Labeling · Standard review | Approved | None posted |
| Nov 3, 2015 | Supplement 28Labeling | Approved | None posted |
| Jan 31, 1997 | Supplement 27Manufacturing | Approved | None posted |
| Feb 4, 1991 | Supplement 26Labeling | Approved | None posted |
| Sep 17, 1990 | Supplement 25Labeling | Approved | None posted |
| Sep 27, 1988 | Supplement 22Manufacturing | Approved | None posted |
| Sep 27, 1988 | Supplement 23Manufacturing | Approved | None posted |
| Sep 27, 1988 | Supplement 24Manufacturing | Approved | None posted |
| Jul 5, 1988 | Supplement 21Labeling | Approved | None posted |
| Oct 26, 1987 | Supplement 18Manufacturing | Approved | None posted |
| May 15, 1987 | Supplement 17Manufacturing | Approved | None posted |
| Feb 5, 1986 | Supplement 14Manufacturing | Approved | None posted |
| Nov 25, 1985 | Supplement 9Manufacturing | Approved | None posted |
| Nov 25, 1985 | Supplement 11Manufacturing | Approved | None posted |
| Nov 25, 1985 | Supplement 12Manufacturing | Approved | None posted |
| Jan 11, 1985 | Supplement 2Manufacturing | Approved | None posted |
| Jan 11, 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
