Mestinon

NDA 9830, held by Bausch. Pyridostigmine Bromide.

As of Nov 14, 2026, NDA 9830 (Mestinon), held by Bausch, was first approved by FDA on Oct 2, 1955, with 9 approved supplements and 0 published complete response letters.

First approved: Oct 2, 1955
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
Oct 2, 1955	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mestinon5MG/ML · injectable;injection	Pyridostigmine Bromide	RxReference drug

All 10 submissions, including labeling and manufacturing supplements


Jul 26, 2001	Supplement 10Labeling · Standard review	Approved	Label
Jul 26, 2001	Supplement 12Labeling · Standard review	Approved	None posted
Dec 7, 1999	Supplement 13Manufacturing · Standard review	Approved	None posted
Nov 7, 1996	Supplement 11Manufacturing · Standard review	Approved	None posted
Oct 27, 1995	Supplement 9Manufacturing · Standard review	Approved	None posted
Jun 12, 1990	Supplement 8Manufacturing · Standard review	Approved	None posted
May 31, 1985	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 16, 1983	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 8, 1980	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 2, 1955	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 9830
Drugs@FDA: Overview at FDA
Company: Bausch Health

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