ANDA 40550, held by Mallinckrodt. Acetaminophen; Oxycodone Hydrochloride.
As of Nov 15, 2026, ANDA 40550 (Oxycodone And Acetaminophen), held by Mallinckrodt, was first approved by FDA on Jun 30, 2004, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 30, 2004 | Original application | Approved | None posted |
| Oxycodone And Acetaminophen500MG;7.5MG · tablet;oral | Acetaminophen; Oxycodone Hydrochloride | Discontinued |
| Oxycodone And Acetaminophen650MG;10MG · 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
