Manages pain severe enough to require an opioid analgesic. NDA 209777, held by Protega Pharms. Oxycodone Hydrochloride.
As of Nov 14, 2026, NDA 209777 (Roxybond), held by Protega Pharms, was first approved by FDA on Apr 20, 2017, with 11 approved supplements and 0 published complete response letters.
ROXYBOND is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 20, 2017 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Roxybond5MG · tablet;oral | Oxycodone Hydrochloride | Rx |
| Roxybond15MG · tablet;oral | Oxycodone Hydrochloride | Rx |
| Roxybond30MG · tablet;oral | Oxycodone Hydrochloride | Rx |
| Roxybond10MG · tablet;oral | Oxycodone Hydrochloride | Rx |
| Jun 18, 2026 | Supplement 16REMS | Approved | |
| Dec 22, 2025 | Supplement 13Labeling · Standard review | Approved | |
| Oct 31, 2024 | Supplement 10REMS | Approved | |
| Sep 5, 2024 | Supplement 11Manufacturing · Standard review | Approved | |
| Apr 19, 2024 | Supplement 9Labeling · Standard review | Approved | |
| Dec 15, 2023 | Supplement 8Labeling · Standard review | Approved | |
| Mar 4, 2021 | Supplement 7Labeling · Standard review | Approved | |
| Oct 7, 2019 | Supplement 6Labeling · Standard review | Approved | |
| Dec 31, 2018 | Supplement 2Labeling · Standard review | Approved | |
| Sep 18, 2018 | Supplement 1REMS | Approved | |
| Sep 18, 2018 | Supplement 3Labeling · Standard review | Approved | |
| Apr 20, 2017 | 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
