Thiothixene

ANDA 71093, held by Rising. Thiothixene.

As of Nov 13, 2026, ANDA 71093 (Thiothixene), held by Rising, was first approved by FDA on Jun 23, 1987, with 16 approved supplements and 0 published complete response letters.

First approved: Jun 23, 1987
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Jun 23, 1987	Original application	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
Thiothixene10MG · capsule;oral	Thiothixene	Rx
Thiothixene1MG · capsule;oral	Thiothixene	Rx
Thiothixene2MG · capsule;oral	Thiothixene	Rx
Thiothixene5MG · capsule;oral	Thiothixene	Rx

All 17 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 22, 2025	Supplement 33Labeling · Standard review	Approved	None posted
Jun 7, 2021	Supplement 30Labeling · Standard review	Approved	None posted
Feb 26, 2010	Supplement 24Labeling	Approved	None posted
Apr 30, 2009	Supplement 21Labeling	Approved	None posted
Aug 19, 2008	Supplement 19Labeling	Approved	None posted
Sep 5, 2002	Supplement 14Labeling	Approved	None posted
Feb 5, 1998	Supplement 13Manufacturing	Approved	None posted
Oct 24, 1995	Supplement 12Manufacturing	Approved	None posted
Nov 19, 1993	Supplement 10Manufacturing	Approved	None posted
Nov 9, 1992	Supplement 1Manufacturing	Approved	None posted
Nov 9, 1992	Supplement 2Manufacturing	Approved	None posted
Jan 31, 1990	Supplement 8Manufacturing	Approved	None posted
Jul 10, 1989	Supplement 7Labeling	Approved	None posted
Jun 16, 1988	Supplement 5Manufacturing	Approved	None posted
Jun 16, 1988	Supplement 6Manufacturing	Approved	None posted
Mar 4, 1988	Supplement 4Labeling	Approved	None posted
Jun 23, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71093
Drugs@FDA: Overview at FDA
Company: Rising 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