Manages acute and chronic pain severe enough to require an opioid analgesic. NDA 202080, held by Zyla. Oxycodone Hydrochloride.
As of Nov 13, 2026, NDA 202080 (Oxaydo), held by Zyla, was first approved by FDA on Jun 17, 2011, with 15 approved supplements and 0 published complete response letters.
OXAYDO is indicated for the management of acute and chronic 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including OXAYDO, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 17, 2011 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxaydo5MG · tablet;oral | Oxycodone Hydrochloride | DiscontinuedReference drug |
| Oxaydo7.5MG · tablet;oral | Oxycodone Hydrochloride | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 18, 2026 | Supplement 17REMS | Approved | |
| Dec 22, 2025 | Supplement 16Labeling · Standard review | Approved | |
| Oct 31, 2024 | Supplement 15REMS | Approved | |
| Apr 19, 2024 | Supplement 14Labeling · Standard review | Approved | |
| Dec 15, 2023 | Supplement 13Labeling · Standard review | Approved | |
| Mar 4, 2021 | Supplement 12Labeling · Standard review | Approved | |
| Oct 7, 2019 | Supplement 11Labeling · Standard review | Approved | |
| Sep 18, 2018 | Supplement 9REMS | Approved | |
| Sep 18, 2018 | Supplement 10Labeling · Standard review | Approved | |
| Dec 16, 2016 | Supplement 5Labeling · Standard review | Approved | |
| Dec 16, 2016 | Supplement 6Labeling · Standard review | Approved | |
| Mar 7, 2016 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Jan 26, 2015 | Supplement 3Labeling · Standard review | Approved | |
| Jan 16, 2014 | Supplement 2Labeling · Standard review | Approved | |
| Jun 3, 2013 | Supplement 1Labeling · Standard review | Approved | |
| Jun 17, 2011 | Original applicationNew formulation or manufacturer · Priority review | 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
