Treats overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and…. ANDA 215781, held by Chartwell Rx. Trospium Chloride.
As of Nov 15, 2026, ANDA 215781 (Trospium Chloride), held by Chartwell Rx, was first approved by FDA on Feb 16, 2022, with 0 approved supplements and 0 published complete response letters.
Trospium chloride tablets is a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 16, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Trospium Chloride20MG · tablet;oral | Trospium 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
