ANDA 85911, held by Bristol Myers Squibb. Acetaminophen; Oxycodone Hydrochloride.
As of Nov 15, 2026, ANDA 85911 (Oxycodone 5/Apap 500), held by Bristol Myers Squibb, was first approved by FDA on Oct 25, 1977, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 25, 1977 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxycodone 5/Apap 500500MG;5MG 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
