Treats overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and…. ANDA 206472, held by Macleods Pharms. Trospium Chloride.
As of Nov 15, 2026, ANDA 206472 (Trospium Chloride), held by Macleods Pharms, was first approved by FDA on Jun 18, 2024, with 0 approved supplements and 0 published complete response letters.
Trospium chloride tablets, 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 |
|---|---|---|---|
| Jun 18, 2024 | 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
