Thioridazine Hydrochloride

ANDA 88271, held by Ani Pharms. Thioridazine Hydrochloride.

As of Nov 15, 2026, ANDA 88271 (Thioridazine Hydrochloride), held by Ani Pharms, was first approved by FDA on Apr 14, 1983, with 10 approved supplements and 0 published complete response letters.

First approved: Apr 14, 1983
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Apr 14, 1983	Original application	Approved	None posted

Products

1 strengths and forms

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

All 11 submissions, including labeling and manufacturing supplements


Jul 16, 1987	Supplement 16Manufacturing	Approved	None posted
Jul 16, 1987	Supplement 15Manufacturing	Approved	None posted
Nov 7, 1986	Supplement 12Manufacturing	Approved	None posted
Nov 7, 1986	Supplement 11Manufacturing	Approved	None posted
Nov 7, 1986	Supplement 10Manufacturing	Approved	None posted
Jun 29, 1984	Supplement 1Manufacturing	Approved	None posted
Jan 17, 1984	Supplement 5Manufacturing	Approved	None posted
Jan 17, 1984	Supplement 4Manufacturing	Approved	None posted
Jan 17, 1984	Supplement 3Manufacturing	Approved	None posted
Nov 2, 1983	Supplement 2Manufacturing	Approved	None posted
Apr 14, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 88271
Drugs@FDA: Overview at FDA
Company: ANI Pharmaceuticals

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