Thioridazine Hydrochloride Intensol

ANDA 88941, held by Roxane. Thioridazine Hydrochloride.

As of Nov 15, 2026, ANDA 88941 (Thioridazine Hydrochloride Intensol), held by Roxane, was first approved by FDA on Dec 16, 1985, with 6 approved supplements and 0 published complete response letters.

First approved: Dec 16, 1985
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Dec 16, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Thioridazine Hydrochloride Intensol30MG/ML · concentrate;oral	Thioridazine Hydrochloride	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Nov 26, 2001	Supplement 8Labeling	Approved	None posted
Feb 28, 1997	Supplement 6Manufacturing	Approved	None posted
Aug 28, 1996	Supplement 7Manufacturing	Approved	None posted
May 22, 1991	Supplement 5Labeling	Approved	None posted
Apr 2, 1990	Supplement 4Labeling	Approved	None posted
Dec 5, 1988	Supplement 3Manufacturing	Approved	None posted
Dec 16, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 88941
Drugs@FDA: Overview at FDA
Company: Roxane 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