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FDA NDA · NDA209777

ROXYBOND

oxycodone hydrochloride

Sponsor: PROTEGA PHARMS

APPLICATION
NDA209777
TYPE
NDA
ORIGINAL APPROVAL
2017-04-20
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ROXYBONDPrescription
OXYCODONE HYDROCHLORIDE 10MG · TABLET · ORAL
ROXYBONDPrescription
OXYCODONE HYDROCHLORIDE 15MG · TABLET · ORAL
ROXYBONDPrescription
OXYCODONE HYDROCHLORIDE 30MG · TABLET · ORAL
ROXYBONDPrescription
OXYCODONE HYDROCHLORIDE 5MG · TABLET · ORAL

Approval history

2026-06-18REMS · Supplement 16 — Letter ↗AP
2025-12-22Labeling · Supplement 13 · standard — Letter ↗AP
2024-10-31REMS · Supplement 10 — Letter ↗AP
2024-09-05Manufacturing (CMC) · Supplement 11 · standard — Medication Guide ↗AP
2024-04-19Labeling · Supplement 9 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 8 · standard — Label ↗AP
2021-03-04Labeling · Supplement 7 · standard — Label ↗AP
2019-10-07Labeling · Supplement 6 · standard — Letter ↗AP
2018-12-31Labeling · Supplement 2 · standard — Label ↗AP
2018-09-18REMS · Supplement 1 — Label ↗AP
2018-09-18Labeling · Supplement 3 · standard — Label ↗AP
2017-04-20Type 5 - New Formulation or New Manufacturer · Original · priority — Other ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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