ANDA 88136, held by Chartwell Rx. Thioridazine Hydrochloride.
As of Nov 15, 2026, ANDA 88136 (Thioridazine Hydrochloride), held by Chartwell Rx, was first approved by FDA on Sep 17, 1986, with 15 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 Hydrochloride150MG · tablet;oral | Thioridazine Hydrochloride | Discontinued |
| Jan 22, 2025 | Supplement 21Labeling · Standard review | Approved | None posted |
| Feb 23, 2017 | Supplement 20Labeling · Standard review | Approved | None posted |
| Apr 19, 2016 | Supplement 19Labeling | Approved | None posted |
| Dec 16, 2002 | Supplement 15Manufacturing | Approved | None posted |
| Sep 5, 2002 | Supplement 14Labeling | Approved | None posted |
| Aug 14, 2001 | Supplement 12Labeling | Approved | None posted |
| Feb 21, 2001 | Supplement 13Manufacturing | Approved | None posted |
| May 5, 1999 | Supplement 10Manufacturing | Approved | None posted |
| Mar 21, 1995 | 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 3Manufacturing | Approved | None posted |
| Jan 9, 1987 | Supplement 2Manufacturing | Approved | None posted |
| Jan 9, 1987 | Supplement 1Manufacturing | 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
