Thioridazine Hydrochloride

ANDA 87264, held by Mutual Pharm. Thioridazine Hydrochloride.

As of Nov 15, 2026, ANDA 87264 (Thioridazine Hydrochloride), held by Mutual Pharm, was first approved by FDA on Nov 18, 1983, with 24 approved supplements and 0 published complete response letters.

First approved: Nov 18, 1983
Supplements approved: 24
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Nov 18, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Thioridazine Hydrochloride25MG · tablet;oral	Thioridazine Hydrochloride	Discontinued

All 25 submissions, including labeling and manufacturing supplements


Dec 3, 2010	Supplement 30Labeling	Approved	None posted
Dec 1, 1998	Supplement 29Manufacturing	Approved	None posted
Dec 23, 1994	Supplement 28Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 27Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 26Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 24Manufacturing	Approved	None posted
Aug 30, 1991	Supplement 23Manufacturing	Approved	None posted
Aug 30, 1991	Supplement 20Manufacturing	Approved	None posted
Jun 12, 1990	Supplement 14Bioequivalence	Approved	None posted
Feb 23, 1990	Supplement 22Labeling	Approved	None posted
Mar 28, 1989	Supplement 19Manufacturing	Approved	None posted
Mar 28, 1989	Supplement 18Labeling	Approved	None posted
Mar 28, 1989	Supplement 17Manufacturing	Approved	None posted
Aug 19, 1988	Supplement 16Labeling	Approved	None posted
Jun 2, 1988	Supplement 15Labeling	Approved	None posted
Mar 3, 1988	Supplement 12Manufacturing	Approved	None posted
Mar 3, 1988	Supplement 11Manufacturing	Approved	None posted
Apr 1, 1987	Supplement 10Manufacturing	Approved	None posted
Apr 17, 1986	Supplement 9Manufacturing	Approved	None posted
Apr 17, 1986	Supplement 8Manufacturing	Approved	None posted
Apr 17, 1986	Supplement 6Manufacturing	Approved	None posted
Apr 17, 1986	Supplement 5Manufacturing	Approved	None posted
Apr 17, 1986	Supplement 4Manufacturing	Approved	None posted
Nov 22, 1985	Supplement 3Manufacturing	Approved	None posted
Nov 18, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 87264
Drugs@FDA: Overview at FDA
Company: Mutual Pharmaceutical Company

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