Treats overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and…. ANDA 91688, held by Invagen Pharms. Trospium Chloride.
As of Nov 15, 2026, ANDA 91688 (Trospium Chloride), held by Invagen Pharms, was first approved by FDA on Aug 23, 2016, with 1 approved supplement 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 23, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Trospium Chloride20MG · tablet;oral | Trospium Chloride | Rx |
| Aug 23, 2016 | Original application | Approved | None posted |
| Aug 23, 2016 | Supplement 1 | 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
