Treats overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and…. ANDA 201291, held by Padagis US. Trospium Chloride.
As of Nov 15, 2026, ANDA 201291 (Trospium Chloride), held by Padagis US, was first approved by FDA on May 24, 2013, 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 |
|---|---|---|---|
| May 24, 2013 | 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
