ANDA 40213, held by Pharm Assoc. Thioridazine Hydrochloride.
As of Nov 15, 2026, ANDA 40213 (Thioridazine Hydrochloride), held by Pharm Assoc, was first approved by FDA on May 29, 1998, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 29, 1998 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Thioridazine Hydrochloride100MG/ML · concentrate;oral | Thioridazine Hydrochloride | Discontinued |
| Jan 22, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Feb 23, 2017 | Supplement 3Labeling · Standard review | Approved | None posted |
| Dec 6, 2010 | Supplement 2Labeling | Approved | None posted |
| May 29, 1998 | 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
