ANDA 88375, held by Mutual Pharm. Thioridazine Hydrochloride.
As of Nov 15, 2026, ANDA 88375 (Thioridazine Hydrochloride), held by Mutual Pharm, was first approved by FDA on Nov 18, 1983, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 18, 1983 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Thioridazine Hydrochloride10MG ยท tablet;oral | Thioridazine Hydrochloride | Discontinued |
| Dec 3, 2010 | Supplement 23Labeling | Approved | None posted |
| Dec 1, 1998 | Supplement 22Manufacturing | Approved | None posted |
| Dec 23, 1994 | Supplement 21Manufacturing | Approved | None posted |
| Oct 11, 1994 | Supplement 20Manufacturing | Approved | None posted |
| Apr 3, 1992 | Supplement 19Manufacturing | Approved | None posted |
| Apr 3, 1992 | Supplement 17Manufacturing | Approved | None posted |
| Feb 23, 1990 | Supplement 15Labeling | Approved | None posted |
| Aug 19, 1988 | Supplement 13Labeling | Approved | None posted |
| Jun 2, 1988 | Supplement 12Labeling | Approved | None posted |
| Mar 3, 1988 | Supplement 10Manufacturing | Approved | None posted |
| Mar 31, 1987 | Supplement 9Manufacturing | Approved | None posted |
| Feb 11, 1986 | Supplement 7Manufacturing | Approved | None posted |
| Feb 11, 1986 | Supplement 6Manufacturing | Approved | None posted |
| Feb 11, 1986 | Supplement 5Manufacturing | Approved | None posted |
| Feb 11, 1986 | Supplement 4Manufacturing | Approved | None posted |
| Nov 18, 1983 | 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
