Thiothixene

ANDA 71530, held by Sandoz. Thiothixene.

As of Nov 13, 2026, ANDA 71530 (Thiothixene), held by Sandoz, was first approved by FDA on Jun 24, 1987, with 18 approved supplements and 0 published complete response letters.

First approved: Jun 24, 1987
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
Jun 24, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Thiothixene10MG · capsule;oral	Thiothixene	Discontinued

All 19 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 8, 2011	Supplement 22Labeling	Approved	None posted
Jan 6, 2010	Supplement 20Labeling	Approved	None posted
Oct 30, 2008	Supplement 19Labeling	Approved	None posted
May 22, 2008	Supplement 18Labeling	Approved	None posted
May 22, 2008	Supplement 17Labeling	Approved	None posted
Dec 31, 2007	Supplement 16Labeling	Approved	None posted
Jul 30, 2003	Supplement 14Labeling	Approved	None posted
Aug 29, 2002	Supplement 13Labeling	Approved	None posted
Nov 6, 2001	Supplement 12Manufacturing	Approved	None posted
Aug 7, 2001	Supplement 11Manufacturing	Approved	None posted
Feb 8, 2001	Supplement 10Manufacturing	Approved	None posted
May 5, 1999	Supplement 9Manufacturing	Approved	None posted
Sep 25, 1998	Supplement 8Labeling	Approved	None posted
Sep 25, 1998	Supplement 7Manufacturing	Approved	None posted
Dec 5, 1997	Supplement 6Manufacturing	Approved	None posted
Apr 18, 1995	Supplement 5Manufacturing	Approved	None posted
Jul 3, 1991	Supplement 4Labeling	Approved	None posted
Feb 17, 1988	Supplement 1Manufacturing	Approved	None posted
Jun 24, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71530
Drugs@FDA: Overview at FDA
Company: Sandoz

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