Thioridazine Hydrochloride

ANDA 88738, held by Sun Pharm Industries. Thioridazine Hydrochloride.

As of Nov 15, 2026, ANDA 88738 (Thioridazine Hydrochloride), held by Sun Pharm Industries, was first approved by FDA on Oct 16, 1984, with 21 approved supplements and 0 published complete response letters.

First approved: Oct 16, 1984
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Oct 16, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Thioridazine Hydrochloride200MG · tablet;oral	Thioridazine Hydrochloride	Discontinued

All 22 submissions, including labeling and manufacturing supplements


Jan 22, 2025	Supplement 25Labeling · Standard review	Approved	None posted
Feb 23, 2017	Supplement 24Labeling · Standard review	Approved	None posted
Dec 3, 2010	Supplement 23Labeling	Approved	None posted
Dec 1, 1998	Supplement 22Manufacturing	Approved	None posted
Dec 23, 1994	Supplement 21Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 20Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 17Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 19Manufacturing	Approved	None posted
Apr 5, 1990	Supplement 16Bioequivalence	Approved	None posted
Feb 23, 1990	Supplement 15Labeling	Approved	None posted
Aug 19, 1988	Supplement 14Labeling	Approved	None posted
Jun 2, 1988	Supplement 13Labeling	Approved	None posted
Dec 28, 1987	Supplement 11Manufacturing	Approved	None posted
Oct 1, 1987	Supplement 9Manufacturing	Approved	None posted
Oct 1, 1987	Supplement 10Manufacturing	Approved	None posted
Apr 3, 1987	Supplement 8Manufacturing	Approved	None posted
Jul 25, 1986	Supplement 6Manufacturing	Approved	None posted
Jul 25, 1986	Supplement 7Manufacturing	Approved	None posted
Feb 11, 1986	Supplement 3Manufacturing	Approved	None posted
Feb 11, 1986	Supplement 4Manufacturing	Approved	None posted
Apr 23, 1985	Supplement 1Manufacturing	Approved	None posted
Oct 16, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 88738
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