ANDA 40199, held by Actavis Elizabeth. Acetaminophen; Oxycodone Hydrochloride.
As of Nov 15, 2026, ANDA 40199 (Oxycodone And Acetaminophen), held by Actavis Elizabeth, was first approved by FDA on Dec 30, 1998, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 30, 1998 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxycodone And Acetaminophen500MG;5MG ยท capsule;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