ANDA 91635, held by Upsher Smith Labs. Trospium Chloride.
As of Nov 15, 2026, ANDA 91635 (Trospium Chloride), held by Upsher Smith Labs, was first approved by FDA on Apr 29, 2015, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 29, 2015 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Trospium Chloride60MG ยท capsule, extended release;oral | Trospium Chloride | Discontinued |
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