ANDA 40304, held by Barr. Acetaminophen; Oxycodone Hydrochloride.
As of Nov 15, 2026, ANDA 40304 (Oxycodone And Acetaminophen), held by Barr, was first approved by FDA on Oct 2, 2000, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 2, 2000 | 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
