ANDA 207113, held by Actavis Labs Fl Inc. Acetaminophen; Oxycodone Hydrochloride.
As of Nov 15, 2026, ANDA 207113 (Acetaminophen; Oxycodone Hydrochloride), held by Actavis Labs Fl Inc, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 27, 2016 | Original application | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetaminophen; Oxycodone Hydrochloride325MG; 7.5MG ยท tablet, extended release;oral | Acetaminophen; Oxycodone Hydrochloride | None (tentative approval) |
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
