Thiothixene

ANDA 70603, held by Chartwell Rx. Thiothixene.

As of Nov 13, 2026, ANDA 70603 (Thiothixene), held by Chartwell Rx, was first approved by FDA on Jun 5, 1987, with 14 approved supplements and 0 published complete response letters.

First approved: Jun 5, 1987
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Jun 5, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Thiothixene10MG · capsule;oral	Thiothixene	Discontinued

All 15 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 22, 2025	Supplement 18Labeling · Standard review	Approved	None posted
Dec 12, 2024	Supplement 17Labeling · Standard review	Approved	None posted
Sep 10, 2002	Supplement 15Labeling	Approved	None posted
Apr 25, 2001	Supplement 16Manufacturing	Approved	None posted
Nov 26, 1997	Supplement 13Manufacturing	Approved	None posted
Jul 20, 1995	Supplement 12Manufacturing	Approved	None posted
Feb 28, 1994	Supplement 11Manufacturing	Approved	None posted
Dec 19, 1991	Supplement 6Manufacturing	Approved	None posted
Dec 19, 1991	Supplement 5Manufacturing	Approved	None posted
Aug 7, 1991	Supplement 9Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 10Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 8Manufacturing	Approved	None posted
Apr 8, 1988	Supplement 4Manufacturing	Approved	None posted
Nov 25, 1987	Supplement 1Manufacturing	Approved	None posted
Jun 5, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 70603
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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