ANDA 90734, held by Ph Health. Acetaminophen; Oxycodone Hydrochloride.
As of Nov 15, 2026, ANDA 90734 (Oxycodone And Acetaminophen), held by Ph Health, was first approved by FDA on Jul 11, 2013, with 14 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 11, 2013 | Original application | Approved |
| Oxycodone And Acetaminophen325MG;7.5MG · tablet;oral | Acetaminophen; Oxycodone Hydrochloride | Discontinued |
| Oxycodone And Acetaminophen325MG;10MG · tablet;oral | Acetaminophen; Oxycodone Hydrochloride | Discontinued |
| Jun 18, 2026 | Supplement 33REMS | Approved | None posted |
| Dec 23, 2025 | Supplement 32Labeling · Standard review | Approved | None posted |
| Oct 31, 2024 | Supplement 31REMS | Approved | None posted |
| Apr 3, 2024 | Supplement 30Labeling · Standard review | Approved | None posted |
| Dec 18, 2023 | Supplement 29Labeling · Standard review | Approved | None posted |
| Dec 18, 2023 | Supplement 28Labeling · Standard review | Approved | None posted |
| Mar 4, 2021 | Supplement 27Labeling · Standard review | Approved | None posted |
| Oct 8, 2019 | Supplement 24Labeling · Standard review | Approved | None posted |
| Sep 21, 2018 | Supplement 22Labeling · Standard review | Approved | None posted |
| Sep 18, 2018 | Supplement 19REMS · Standard review | Approved | None posted |
| Dec 16, 2016 | Supplement 16Labeling · Standard review | Approved | None posted |
| Dec 16, 2016 | Supplement 14Labeling · Standard review | Approved | None posted |
| Dec 16, 2016 | Supplement 12Labeling · Standard review | Approved | None posted |
| Oct 18, 2013 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 11, 2013 | 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
