Torecan

NDA 13247, held by Novartis. Thiethylperazine Maleate.

As of Nov 13, 2026, NDA 13247 (Torecan), held by Novartis, was first approved by FDA on Apr 11, 1963, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 11, 1963
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Apr 11, 1963	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Torecan10MG · suppository;rectal	Thiethylperazine Maleate	Discontinued

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 7, 1993	Supplement 21Manufacturing · Standard review	Approved	None posted
Mar 5, 1990	Supplement 18Manufacturing · Standard review	Approved	None posted
Sep 12, 1988	Supplement 14Manufacturing · Standard review	Approved	None posted
Sep 26, 1986	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 11, 1963	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 13247
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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