ANDA 71554, held by Teva Pharms. Thiothixene Hydrochloride.
As of Nov 15, 2026, ANDA 71554 (Thiothixene Hydrochloride), held by Teva Pharms, was first approved by FDA on Oct 16, 1987, with 14 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 16, 1987 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Thiothixene HydrochlorideEQ 5MG BASE/ML ยท concentrate;oral | Thiothixene Hydrochloride | Discontinued |
| Sep 11, 2002 | Supplement 16Labeling | Approved | None posted |
| Jan 23, 2002 | Supplement 11Manufacturing | Approved | None posted |
| Oct 31, 2001 | Supplement 13Manufacturing | Approved | None posted |
| Oct 31, 2001 | Supplement 14Manufacturing | Approved | None posted |
| Oct 31, 2001 | Supplement 15Manufacturing | Approved | None posted |
| Feb 26, 2001 | Supplement 10Manufacturing | Approved | None posted |
| Jun 17, 1999 | Supplement 8Manufacturing | Approved | None posted |
| Mar 23, 1999 | Supplement 7Manufacturing | Approved | None posted |
| Jun 11, 1998 | Supplement 6Manufacturing | Approved | None posted |
| May 31, 1996 | Supplement 5Manufacturing | Approved | None posted |
| Nov 17, 1992 | Supplement 3Manufacturing | Approved | None posted |
| Nov 17, 1992 | Supplement 4Manufacturing | Approved | None posted |
| Jun 7, 1991 | Supplement 2Manufacturing | Approved | None posted |
| Feb 14, 1990 | Supplement 1Labeling | Approved | None posted |
| Oct 16, 1987 | 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
