Treats acute postoperative and postpartum nonobstructive (functional) urinary retention. ANDA 40634, held by Upsher Smith Labs. Bethanechol Chloride.
As of Nov 15, 2026, ANDA 40634 (Bethanechol Chloride), held by Upsher Smith Labs, was first approved by FDA on Jun 1, 2005, 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 |
|---|---|---|---|
| Jun 1, 2005 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bethanechol Chloride10MG · 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
