ANDA 85839, held by Watson Labs. Bethanechol Chloride.
As of Nov 15, 2026, ANDA 85839 (Bethanechol Chloride), held by Watson Labs, was first approved by FDA on Aug 26, 1977, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 26, 1977 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bethanechol Chloride25MG ยท tablet;oral | Bethanechol Chloride | Discontinued |
| Dec 20, 1988 | Supplement 21Labeling | Approved | None posted |
| Aug 26, 1977 | Original application | 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
