Mestinon

Treats myasthenia gravis. NDA 11665, held by Bausch. Pyridostigmine Bromide.

As of Nov 13, 2026, NDA 11665 (Mestinon), held by Bausch, was first approved by FDA on Jan 12, 1959, with 13 approved supplements and 0 published complete response letters.

First approved: Jan 12, 1959
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATION: MESTINON is useful in the treatment of myasthenia gravis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Jan 12, 1959	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mestinon180MG · tablet, extended release;oral	Pyridostigmine Bromide	RxReference drug

All 14 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 25, 2014	Supplement 20Manufacturing · Standard review	Approved	None posted
Jan 3, 2014	Supplement 19Manufacturing · Standard review	Approved	None posted
Aug 14, 2001	Supplement 18Manufacturing · Standard review	Approved	None posted
Jul 26, 2001	Supplement 15Labeling · Standard review	Approved	Label
Jul 26, 2001	Supplement 13Labeling · Standard review	Approved	None posted
Feb 13, 2001	Supplement 17Manufacturing · Standard review	Approved	None posted
Nov 7, 1996	Supplement 16Manufacturing · Standard review	Approved	None posted
Oct 24, 1995	Supplement 14Manufacturing · Standard review	Approved	None posted
Jul 18, 1989	Supplement 11Manufacturing · Standard review	Approved	None posted
Jan 27, 1986	Supplement 10Labeling	Approved	None posted
Nov 22, 1978	Supplement 8Manufacturing · Standard review	Approved	None posted
Feb 16, 1978	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 9, 1977	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 12, 1959	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 11665
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