Cantil

NDA 10679, held by Sanofi Aventis US. Mepenzolate Bromide.

As of Nov 13, 2026, NDA 10679 (Cantil), held by Sanofi Aventis US, was first approved by FDA on Nov 14, 1956, with 9 approved supplements and 0 published complete response letters.

First approved: Nov 14, 1956
Review: Standard
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Nov 14, 1956	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Cantil25MG · tablet;oral	Mepenzolate Bromide	DiscontinuedReference drug
Cantil25MG/5ML · solution;oral	Mepenzolate Bromide	Discontinued

All 10 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 25, 2004	Supplement 29Labeling · Standard review	Approved	Letter Label
Jan 29, 1999	Supplement 27Manufacturing · Standard review	Approved	None posted
May 8, 1991	Supplement 23Labeling	Approved	None posted
Jan 11, 1989	Supplement 26Manufacturing · Standard review	Approved	None posted
Jul 15, 1985	Supplement 25Manufacturing · Standard review	Approved	None posted
Nov 9, 1982	Supplement 19Manufacturing · Standard review	Approved	None posted
Nov 9, 1982	Supplement 24Manufacturing · Standard review	Approved	None posted
Nov 4, 1980	Supplement 21Labeling	Approved	None posted
Jun 20, 1980	Supplement 17Labeling	Approved	None posted
Nov 14, 1956	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 10679
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