NDA 20414, held by US Army. Pyridostigmine Bromide.
As of Nov 14, 2026, NDA 20414 (Pyridostigmine Bromide), held by US Army, was first approved by FDA on Feb 5, 2003, with 5 approved supplements and 0 published complete response letters.
Pyridostigmine bromide is indicated for pretreatment against the lethal effects of soman nerve agent poisoning in adults. Pyridostigmine bromide is intended for use in conjunction with protective garments, including a mask. At the first sign of nerve agent poisoning, pyridostigmine bromide should be stopped, and atropine and pralidoxime therapy started immediately. The evidence for the effectiveness of pyridostigmine bromide as pretreatment against soman-induced toxicity was derived from animal studies alone. FOR MILITARY MEDICAL USE ONLY
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 5, 2003 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pyridostigmine Bromide30MG · tablet;oral | Pyridostigmine Bromide | Discontinued |
| Sep 26, 2025 | Supplement 12Labeling · Standard review | Approved | |
| Oct 4, 2024 | Supplement 11Manufacturing | Approved | |
| Dec 23, 2015 | Supplement 4Manufacturing · Priority review | Approved | |
| Sep 30, 2014 | Supplement 3Manufacturing · Priority review | Approved | |
| Jan 3, 2014 | Supplement 2Manufacturing · Priority review | Approved | |
| Feb 5, 2003 | Original applicationNew dosage form · Priority review | Approved |
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
