ANDA 84188, held by Glenwood. Bethanechol Chloride.
As of Nov 15, 2026, ANDA 84188 (Myotonachol), held by Glenwood, was first approved by FDA on Sep 24, 1975, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 24, 1975 | Original application | Approved | None posted |
| Myotonachol5MG · tablet;oral | Bethanechol Chloride | Discontinued |
| Myotonachol10MG · tablet;oral | Bethanechol Chloride | Discontinued |
| Myotonachol25MG · tablet;oral | Bethanechol Chloride | Discontinued |
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
