Thioridazine Hydrochloride

ANDA 89103, held by Superpharm. Thioridazine Hydrochloride.

As of Nov 15, 2026, ANDA 89103 (Thioridazine Hydrochloride), held by Superpharm, was first approved by FDA on Jul 2, 1985, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 2, 1985
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jul 2, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Thioridazine Hydrochloride10MG · tablet;oral	Thioridazine Hydrochloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jun 19, 1991	Supplement 16Labeling	Approved	None posted
Feb 8, 1989	Supplement 13Labeling	Approved	None posted
Jul 2, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 89103
Drugs@FDA: Overview at FDA
Company: Superpharm

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