ANDA 88137, held by Chartwell Rx. Thioridazine Hydrochloride.
As of Nov 15, 2026, ANDA 88137 (Thioridazine Hydrochloride), held by Chartwell Rx, was first approved by FDA on Sep 17, 1986, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 17, 1986 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Thioridazine Hydrochloride200MG · tablet;oral | Thioridazine Hydrochloride | Discontinued |
| Jan 22, 2025 | Supplement 22Labeling · Standard review | Approved | None posted |
| Feb 23, 2017 | Supplement 21Labeling · Standard review | Approved | None posted |
| Apr 22, 2016 | Supplement 20Labeling | Approved | None posted |
| Dec 16, 2002 | Supplement 16Manufacturing | Approved | None posted |
| Sep 5, 2002 | Supplement 15Labeling | Approved | None posted |
| Aug 14, 2001 | Supplement 13Labeling | Approved | None posted |
| Feb 21, 2001 | Supplement 14Manufacturing | Approved | None posted |
| May 5, 1999 | Supplement 11Manufacturing | Approved | None posted |
| Mar 21, 1995 | Supplement 10Manufacturing | Approved | None posted |
| Mar 2, 1992 | Supplement 9Manufacturing | Approved | None posted |
| Jan 9, 1990 | Supplement 8Labeling | Approved | None posted |
| Sep 28, 1989 | Supplement 7Labeling | Approved | None posted |
| Nov 10, 1988 | Supplement 6Manufacturing | Approved | None posted |
| Jan 9, 1987 | Supplement 1Manufacturing | Approved | None posted |
| Jan 9, 1987 | Supplement 2Manufacturing | Approved | None posted |
| Jan 9, 1987 | Supplement 3Manufacturing | Approved | None posted |
| Sep 17, 1986 | 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
