Taractan

NDA 12486, held by Roche. Chlorprothixene.

As of Nov 14, 2026, NDA 12486 (Taractan), held by Roche, was first approved by FDA on May 7, 1962, with 11 approved supplements and 0 published complete response letters.

First approved: May 7, 1962
Review: Standard
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
May 7, 1962	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

4 strengths and forms


Taractan100MG · tablet;oral	Chlorprothixene	Discontinued
Taractan50MG · tablet;oral	Chlorprothixene	Discontinued
Taractan25MG · tablet;oral	Chlorprothixene	Discontinued
Taractan10MG · tablet;oral	Chlorprothixene	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Jan 9, 1997	Supplement 12Labeling	Approved	None posted
Jan 9, 1997	Supplement 31Labeling	Approved	None posted
Jan 9, 1997	Supplement 36Labeling	Approved	None posted
Jan 9, 1997	Supplement 40Labeling	Approved	None posted
Jan 9, 1997	Supplement 44Labeling	Approved	None posted
Jan 9, 1997	Supplement 46Labeling	Approved	None posted
Jan 9, 1997	Supplement 47Labeling	Approved	None posted
Jan 9, 1997	Supplement 48Labeling	Approved	None posted
Jan 9, 1997	Supplement 49Labeling	Approved	None posted
Jan 29, 1981	Supplement 45Labeling	Approved	None posted
Jun 16, 1974	Supplement 26Labeling	Approved	None posted
May 7, 1962	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 12486
Drugs@FDA: Overview at FDA
Company: Roche

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