Treats acute postoperative and postpartum nonobstructive (functional) urinary retention. ANDA 40728, held by Chartwell Rx. Bethanechol Chloride.
As of Nov 15, 2026, ANDA 40728 (Bethanechol Chloride), held by Chartwell Rx, was first approved by FDA on Oct 26, 2007, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Bethanechol Chloride Tablets, USP are indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 26, 2007 | Original application | Approved | None posted |
| Bethanechol Chloride50MG · tablet;oral | Bethanechol Chloride | Rx |
| Bethanechol Chloride5MG · tablet;oral | Bethanechol Chloride | Rx |
| Bethanechol Chloride10MG · tablet;oral | Bethanechol Chloride | Rx |
| Bethanechol Chloride25MG · tablet;oral | Bethanechol Chloride | Rx |
| May 8, 2019 | Supplement 2Manufacturing | Approved | None posted |
| Oct 26, 2007 | 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
