Treats overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and…. ANDA 214760, held by Utopic Pharms. Trospium Chloride.
As of Nov 15, 2026, ANDA 214760 (Trospium Chloride), held by Utopic Pharms, was first approved by FDA on Apr 30, 2021, with 0 approved supplements and 0 published complete response letters.
Trospium Chloride Extended-Release Capsules are 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 |
|---|---|---|---|
| Apr 30, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Trospium Chloride60MG · capsule, extended release;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
