ANDA 40676, held by Mikart. Acetaminophen; Oxycodone Hydrochloride.
As of Nov 15, 2026, ANDA 40676 (Oxycodone And Acetaminophen), held by Mikart, was first approved by FDA on Apr 19, 2006, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 19, 2006 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxycodone And Acetaminophen500MG;10MG ยท tablet;oral | Acetaminophen; Oxycodone Hydrochloride | 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
