ANDA 40187, held by Pharm Assoc. Thioridazine Hydrochloride.
As of Nov 15, 2026, ANDA 40187 (Thioridazine Hydrochloride), held by Pharm Assoc, was first approved by FDA on Aug 28, 1997, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 28, 1997 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Thioridazine Hydrochloride30MG/ML · concentrate;oral | Thioridazine Hydrochloride | Discontinued |
| Jan 22, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| Feb 23, 2017 | Supplement 4Labeling · Standard review | Approved | None posted |
| Dec 6, 2010 | Supplement 3Labeling | Approved | None posted |
| Oct 31, 2002 | Supplement 1Labeling | Approved | None posted |
| Aug 28, 1997 | Original application | Approved |
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
