Thioridazine Hydrochloride

ANDA 88562, held by Watson Labs. Thioridazine Hydrochloride.

As of Nov 15, 2026, ANDA 88562 (Thioridazine Hydrochloride), held by Watson Labs, was first approved by FDA on May 11, 1984, with 1 approved supplement and 0 published complete response letters.

First approved: May 11, 1984
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
May 11, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Thioridazine Hydrochloride15MG · tablet;oral	Thioridazine Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jul 5, 1988	Supplement 11Labeling	Approved	None posted
May 11, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 88562
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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