ANDA 86262, held by Chartwell Rx. Bethanechol Chloride.
As of Nov 15, 2026, ANDA 86262 (Duvoid), held by Chartwell Rx, was first approved by FDA on Mar 22, 1978, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 22, 1978 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Duvoid10MG ยท tablet;oral | Bethanechol Chloride | Rx |
| Jun 28, 2004 | Supplement 21Labeling | Approved | None posted |
| Dec 28, 1989 | Supplement 14Labeling | Approved | None posted |
| Nov 15, 1988 | Supplement 13Labeling | Approved | None posted |
| Sep 29, 1983 | Supplement 12Manufacturing | Approved | None posted |
| Mar 22, 1978 | 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