Manages pain severe enough to require an opioid analgesic. NDA 21011, held by Specgx LLC. Oxycodone Hydrochloride.
As of Nov 13, 2026, NDA 21011 (Roxicodone), held by Specgx LLC, was first approved by FDA on Aug 31, 2000, with 12 approved supplements and 0 published complete response letters.
ROXICODONE is 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including ROXICODONE 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 |
|---|---|---|---|
| Aug 31, 2000 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Roxicodone15MG · tablet;oral | Oxycodone Hydrochloride | RxReference drug |
| Roxicodone30MG · tablet;oral | Oxycodone Hydrochloride | RxReference drug |
| Roxicodone5MG · tablet;oral | Oxycodone Hydrochloride | RxReference 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 11Labeling · Standard review | Approved | |
| Oct 7, 2019 | Supplement 10Labeling · Standard review | Approved | |
| Sep 18, 2018 | Supplement 8REMS | Approved | |
| Sep 18, 2018 | Supplement 9Labeling · Standard review | Approved | |
| Dec 16, 2016 | Supplement 6Labeling · Standard review | Approved | |
| May 15, 2009 | Supplement 3Manufacturing | Approved | |
| Feb 20, 2009 | Supplement 2Labeling · Standard review | Approved | |
| Aug 31, 2000 | Original applicationNew dosage form · Standard 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
