ANDA 75137, held by Pharm Assoc. Oxybutynin Chloride.
As of Nov 15, 2026, ANDA 75137 (Oxybutynin Chloride), held by Pharm Assoc, was first approved by FDA on Dec 18, 1998, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 18, 1998 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxybutynin Chloride5MG/5ML ยท syrup;oral | Oxybutynin 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