Miochol

NDA 16211, held by Novartis. Acetylcholine Chloride.

As of Nov 14, 2026, NDA 16211 (Miochol), held by Novartis, was first approved by FDA on Oct 9, 1973, with 15 approved supplements and 0 published complete response letters.

First approved: Oct 9, 1973
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Oct 9, 1973	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Miochol20MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · for solution;ophthalmic	Acetylcholine Chloride	DiscontinuedReference drug

All 16 submissions, including labeling and manufacturing supplements


Oct 16, 1996	Supplement 24Manufacturing · Standard review	Approved	None posted
Jul 30, 1996	Supplement 23Labeling · Standard review	Approved	None posted
Oct 31, 1990	Supplement 19Labeling · Standard review	Approved	None posted
Oct 17, 1988	Supplement 17Labeling · Standard review	Approved	None posted
Dec 4, 1987	Supplement 20Manufacturing · Standard review	Approved	None posted
Mar 30, 1987	Supplement 13Labeling · Standard review	Approved	None posted
Oct 24, 1986	Supplement 12Labeling · Standard review	Approved	None posted
Sep 4, 1985	Supplement 18Manufacturing · Standard review	Approved	None posted
Apr 29, 1985	Supplement 15Manufacturing · Standard review	Approved	None posted
May 8, 1984	Supplement 16Labeling · Standard review	Approved	None posted
Dec 6, 1983	Supplement 14Manufacturing · Standard review	Approved	None posted
Jul 20, 1981	Supplement 11Manufacturing · Standard review	Approved	None posted
Jun 25, 1981	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 16, 1979	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 10, 1977	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 9, 1973	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 16211
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