Mytelase

NDA 10155, held by Sanofi Aventis US. Ambenonium Chloride.

As of Nov 13, 2026, NDA 10155 (Mytelase), held by Sanofi Aventis US, was first approved by FDA on May 1, 1956, with 16 approved supplements and 0 published complete response letters.

First approved: May 1, 1956
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
May 1, 1956	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mytelase10MG · tablet;oral	Ambenonium Chloride	Discontinued

All 17 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 26, 2014	Supplement 24Labeling · Standard review	Approved	Label Letter
Nov 14, 2011	Supplement 22Labeling · Standard review	Approved	Letter Label
Nov 14, 2011	Supplement 23Labeling · Standard review	Approved	Letter Label
Feb 26, 2003	Supplement 21Labeling · Standard review	Approved	Letter
Mar 27, 2002	Supplement 20Manufacturing · Standard review	Approved	None posted
Dec 2, 1991	Supplement 18Manufacturing · Standard review	Approved	None posted
Dec 2, 1991	Supplement 19Manufacturing · Standard review	Approved	None posted
Mar 9, 1990	Supplement 17Manufacturing · Standard review	Approved	None posted
Jan 3, 1986	Supplement 15Labeling	Approved	None posted
Apr 1, 1982	Supplement 13Manufacturing · Standard review	Approved	None posted
Apr 20, 1981	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 18, 1981	Supplement 11Manufacturing · Standard review	Approved	None posted
Apr 2, 1980	Supplement 10Labeling	Approved	None posted
Feb 6, 1980	Supplement 9Manufacturing · Standard review	Approved	None posted
Dec 20, 1977	Supplement 7Labeling	Approved	None posted
Dec 20, 1977	Supplement 8Labeling	Approved	None posted
May 1, 1956	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 10155
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