NDA 12754, held by Novartis. Thiethylperazine Malate.
As of Nov 13, 2026, NDA 12754 (Torecan), held by Novartis, was first approved by FDA on Jul 18, 1961, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 18, 1961 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Torecan5MG/ML · injectable;injection | Thiethylperazine Malate | Discontinued |
| May 10, 2001 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1997 | Supplement 25Labeling | Approved | None posted |
| Aug 6, 1997 | Supplement 28Labeling | Approved | None posted |
| Aug 6, 1997 | Supplement 34Labeling · Standard review | Approved | None posted |
| Dec 17, 1996 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Sep 19, 1995 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Sep 14, 1993 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Sep 2, 1993 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Jul 8, 1993 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Sep 22, 1989 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1989 | Supplement 23Labeling | Approved | None posted |
| Feb 28, 1989 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Apr 20, 1988 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Jul 18, 1961 | Original applicationNew dosage form · Standard review | Approved | None posted |
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
