Manages pain severe enough to require an opioid analgesic. ANDA 40910, held by Epic Pharma LLC. Aspirin; Oxycodone Hydrochloride.
As of Nov 15, 2026, ANDA 40910 (Oxycodone And Aspirin), held by Epic Pharma LLC, was first approved by FDA on Jul 16, 2020, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Oxycodone and aspirin tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration (see WARNINGS ), reserve oxycodone and aspirin tablets for use in patients for whom alternative treatment options (e.g.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 16, 2020 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxycodone And Aspirin325MG;4.8355MG · tablet;oral | Aspirin; Oxycodone Hydrochloride | Discontinued |
| Jun 18, 2026 | Supplement 6REMS | Approved | None posted |
| Mar 7, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| Nov 21, 2024 | Supplement 4Labeling · Standard review | Approved | None posted |
| Oct 31, 2024 | Supplement 3REMS | Approved | None posted |
| Jul 16, 2020 | 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
