Treats overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and…. ANDA 204945, held by Heritage Pharms Inc. Trospium Chloride.
As of Nov 15, 2026, ANDA 204945 (Trospium Chloride), held by Heritage Pharms Inc, was first approved by FDA on Aug 30, 2016, 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 |
|---|---|---|---|
| Aug 30, 2016 | 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
