ANDA 74868, held by Pharmobedient Cnsltg. Oxybutynin Chloride.
As of Nov 15, 2026, ANDA 74868 (Oxybutynin Chloride), held by Pharmobedient Cnsltg, was first approved by FDA on Feb 12, 1997, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 12, 1997 | Original application | Approved | None posted |
| 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
