Thioridazine Hydrochloride

ANDA 88461, held by Sun Pharm Industries. Thioridazine Hydrochloride.

As of Nov 15, 2026, ANDA 88461 (Thioridazine Hydrochloride), held by Sun Pharm Industries, was first approved by FDA on Nov 18, 1983, with 18 approved supplements and 0 published complete response letters.

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

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

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

Products

1 strengths and forms

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

All 19 submissions, including labeling and manufacturing supplements


Jan 22, 2025	Supplement 23Labeling · Standard review	Approved	None posted
Feb 23, 2017	Supplement 22Labeling · Standard review	Approved	None posted
Dec 3, 2010	Supplement 21Labeling	Approved	None posted
Dec 1, 1998	Supplement 20Manufacturing	Approved	None posted
Dec 23, 1994	Supplement 19Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 18Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 15Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 17Manufacturing	Approved	None posted
Feb 23, 1990	Supplement 14Labeling	Approved	None posted
Aug 19, 1988	Supplement 12Labeling	Approved	None posted
Jun 2, 1988	Supplement 11Labeling	Approved	None posted
Mar 3, 1988	Supplement 9Manufacturing	Approved	None posted
Mar 31, 1987	Supplement 8Manufacturing	Approved	None posted
Apr 8, 1986	Supplement 7Manufacturing	Approved	None posted
Feb 11, 1986	Supplement 4Manufacturing	Approved	None posted
Feb 11, 1986	Supplement 5Manufacturing	Approved	None posted
Jan 22, 1986	Supplement 6Manufacturing	Approved	None posted
Oct 5, 1984	Supplement 2Manufacturing	Approved	None posted
Nov 18, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 88461
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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