ANDA 78293, held by Mylan Pharms Inc. Oxybutynin Chloride.
As of Nov 15, 2026, ANDA 78293 (Oxybutynin Chloride), held by Mylan Pharms Inc, was first approved by FDA on May 10, 2007, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 10, 2007 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxybutynin Chloride15 MG. ยท tablet, extended release; 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
