ANDA 213550, held by Regcon Holdings. Oxybutynin Chloride.
As of Nov 15, 2026, ANDA 213550 (Oxybutynin Chloride), held by Regcon Holdings, was first approved by FDA on Jul 14, 2022, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 14, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxybutynin Chloride5MG ยท tablet;oral | Oxybutynin 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
