Taractan

NDA 12487, held by Roche. Chlorprothixene.

As of Nov 13, 2026, NDA 12487 (Taractan), held by Roche, was first approved by FDA on Mar 23, 1962, with 10 approved supplements and 0 published complete response letters.

First approved: Mar 23, 1962
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Mar 23, 1962	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Taractan12.5MG/ML · injectable;injection	Chlorprothixene	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Jun 25, 1997	Supplement 14Labeling	Approved	None posted
Jun 25, 1997	Supplement 18Labeling	Approved	None posted
Jun 25, 1997	Supplement 20Labeling	Approved	None posted
Jun 25, 1997	Supplement 23Labeling	Approved	None posted
Jun 25, 1997	Supplement 24Labeling	Approved	None posted
Jun 25, 1997	Supplement 25Labeling	Approved	None posted
Sep 27, 1984	Supplement 21Labeling	Approved	None posted
Jan 29, 1981	Supplement 19Labeling	Approved	None posted
Jan 8, 1979	Supplement 17Labeling	Approved	None posted
Jun 16, 1974	Supplement 12Labeling	Approved	None posted
Mar 23, 1962	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 12487
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