Treats acute postoperative and postpartum nonobstructive (functional) urinary retention. ANDA 40855, held by Amneal Pharm. Bethanechol Chloride.
As of Nov 15, 2026, ANDA 40855 (Bethanechol Chloride), held by Amneal Pharm, was first approved by FDA on Nov 21, 2007, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Bethanechol chloride tablets 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 |
|---|---|---|---|
| Nov 21, 2007 | Original application | Approved | None posted |
| Bethanechol Chloride5MG · tablet;oral | Bethanechol Chloride | Rx |
| Bethanechol Chloride10MG · tablet;oral | Bethanechol Chloride | Rx |
| Bethanechol Chloride25MG · tablet;oral | Bethanechol Chloride | Rx |
| Bethanechol Chloride50MG · tablet;oral | Bethanechol Chloride | Rx |
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
