ANDA 40203, held by Actavis Elizabeth. Acetaminophen; Oxycodone Hydrochloride.
As of Nov 15, 2026, ANDA 40203 (Oxycodone And Acetaminophen), held by Actavis Elizabeth, was first approved by FDA on Mar 15, 1999, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 15, 1999 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxycodone And Acetaminophen325MG;5MG · tablet;oral | Acetaminophen; Oxycodone Hydrochloride | Discontinued |
| Jun 18, 2026 | Supplement 19REMS | Approved | None posted |
| Dec 22, 2025 | Supplement 18Labeling · Standard review | Approved | None posted |
| Oct 31, 2024 | Supplement 17REMS | Approved | None posted |
| Mar 12, 2024 | Supplement 16Labeling · Standard review | Approved | None posted |
| Mar 12, 2024 | Supplement 15Labeling · Standard review | Approved | None posted |
| Dec 15, 2023 | Supplement 14Labeling · Standard review | Approved | None posted |
| Dec 15, 2023 | Supplement 13Labeling · Standard review | Approved | None posted |
| Mar 4, 2021 | Supplement 12Labeling · Standard review | Approved | None posted |
| Oct 11, 2019 | Supplement 11Labeling · Standard review | Approved | None posted |
| Sep 21, 2018 | Supplement 10Labeling · Standard review | Approved | None posted |
| Sep 18, 2018 | Supplement 9REMS | Approved | None posted |
| Dec 16, 2016 | Supplement 8Labeling · Standard review | Approved | None posted |
| Dec 16, 2016 | Supplement 7Labeling · Standard review | Approved | None posted |
| Mar 28, 2016 | Supplement 6Labeling · Standard review | Approved | None posted |
| Mar 28, 2016 | Supplement 5Labeling | Approved | None posted |
| Mar 15, 1999 | Original application | Approved |
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
