Taractan

NDA 16149, held by Roche. Chlorprothixene.

As of Nov 14, 2026, NDA 16149 (Taractan), held by Roche, was first approved by FDA on Jun 19, 1967, with 6 approved supplements and 0 published complete response letters.

First approved: Jun 19, 1967
Review: Standard
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Jun 19, 1967	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Taractan100MG/5ML · concentrate;oral	Chlorprothixene	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Jan 29, 1981	Supplement 24Labeling · Standard review	Approved	None posted
May 4, 1979	Supplement 20Manufacturing · Standard review	Approved	None posted
Jan 10, 1979	Supplement 21Labeling · Standard review	Approved	None posted
Jan 10, 1979	Supplement 22Manufacturing · Standard review	Approved	None posted
Sep 10, 1976	Supplement 19Manufacturing · Standard review	Approved	None posted
Jun 16, 1974	Supplement 13Labeling · Standard review	Approved	None posted
Jun 19, 1967	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 16149
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