Treats myasthenia gravis. NDA 15193, held by Bausch. Pyridostigmine Bromide.
As of Nov 13, 2026, NDA 15193 (Mestinon), held by Bausch, was first approved by FDA on Jan 25, 1965, with 11 approved supplements and 0 published complete response letters.
INDICATION: MESTINON is useful in the treatment of myasthenia gravis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 25, 1965 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mestinon60MG/5ML · syrup;oral | Pyridostigmine Bromide | RxReference drug |
| Oct 29, 2019 | Supplement 27Labeling · Standard review | Approved | |
| Feb 23, 2015 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Sep 30, 2014 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Sep 26, 2013 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| May 22, 2002 | Supplement 20Manufacturing · Standard review | Approved | |
| Jul 26, 2001 | Supplement 18Labeling · Standard review | Approved | |
| Nov 7, 1996 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Oct 27, 1995 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Jun 17, 1993 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Jan 27, 1986 | Supplement 14Labeling | Approved | None posted |
| Feb 4, 1982 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Jan 25, 1965 | Original applicationNew dosage form · Standard review | Approved | None posted |
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
