Treats acute postoperative and postpartum nonobstructive (functional) urinary retention. ANDA 91256, held by Heritage Pharma. Bethanechol Chloride.
As of Nov 15, 2026, ANDA 91256 (Bethanechol Chloride), held by Heritage Pharma, was first approved by FDA on May 4, 2010, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Bethanechol chloride is 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 |
|---|---|---|---|
| May 4, 2010 | 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
