Trancopal

NDA 11467, held by Sanofi Aventis US. Chlormezanone.

As of Nov 15, 2026, NDA 11467 (Trancopal), held by Sanofi Aventis US, was first approved by FDA on May 20, 1960, with 21 approved supplements and 0 published complete response letters.

First approved: May 20, 1960
Review: Standard
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
May 20, 1960	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms


Trancopal100MG · tablet;oral	Chlormezanone	Discontinued
Trancopal200MG · tablet;oral	Chlormezanone	Discontinued

All 22 submissions, including labeling and manufacturing supplements


Mar 13, 2009	Supplement 25Labeling	Approved	None posted
Mar 13, 2009	Supplement 22Labeling	Approved	None posted
Mar 13, 2009	Supplement 17Labeling	Approved	None posted
Mar 13, 2009	Supplement 8Labeling	Approved	None posted
Feb 15, 1995	Supplement 30Manufacturing · Standard review	Approved	None posted
Sep 30, 1993	Supplement 28Manufacturing · Standard review	Approved	None posted
Jun 8, 1993	Supplement 29Manufacturing · Standard review	Approved	None posted
May 25, 1993	Supplement 24Manufacturing · Standard review	Approved	None posted
Nov 8, 1991	Supplement 19Manufacturing · Standard review	Approved	None posted
Jul 25, 1990	Supplement 27Manufacturing · Standard review	Approved	None posted
Jan 20, 1988	Supplement 23Labeling	Approved	None posted
Jan 28, 1987	Supplement 20Manufacturing · Standard review	Approved	None posted
Oct 29, 1985	Supplement 21Labeling	Approved	None posted
Aug 29, 1984	Supplement 16Manufacturing · Standard review	Approved	None posted
Aug 22, 1984	Supplement 18Manufacturing · Standard review	Approved	None posted
Jan 24, 1984	Supplement 15Manufacturing · Standard review	Approved	None posted
Dec 17, 1981	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 10, 1981	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 5, 1979	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 4, 1979	Supplement 9Labeling	Approved	None posted
Dec 14, 1976	Supplement 6Manufacturing · Standard review	Approved	None posted
May 20, 1960	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 11467
Drugs@FDA: Overview at FDA
Company: sanofi-aventis US

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