Treats overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and…. ANDA 213185, held by Granules. Trospium Chloride.
As of Nov 15, 2026, ANDA 213185 (Trospium Chloride), held by Granules, was first approved by FDA on Apr 23, 2020, with 1 approved supplement 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 23, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Trospium Chloride60MG · capsule, extended release;oral | Trospium Chloride | Rx |
| Oct 7, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 23, 2020 | Original application | Approved | None posted |
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
