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FDA NDA · NDA200534

OXYCODONE HYDROCHLORIDE

Sponsor: GENUS LIFESCIENCES

APPLICATION
NDA200534
TYPE
NDA
ORIGINAL APPROVAL
2010-10-20
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

OXYCODONE HYDROCHLORIDE · ReferencePrescription
OXYCODONE HYDROCHLORIDE 5MG · CAPSULE · ORAL

Approval history

2026-06-18REMS · Supplement 19 — Letter ↗AP
2025-12-22Labeling · Supplement 17 · standard — Letter ↗AP
2024-10-31REMS · Supplement 15 — Letter ↗AP
2024-04-19Labeling · Supplement 14 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 13 · standard — Label ↗AP
2021-07-21Efficacy · Supplement 10 · standard — Letter ↗AP
2021-03-04Labeling · Supplement 11 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 9 · standard — Label ↗AP
2018-09-18Labeling · Supplement 8 · standard — Letter ↗AP
2018-09-18REMS · Supplement 7 — Letter ↗AP
2016-12-16Labeling · Supplement 6 · standard — Label ↗AP
2015-11-16Manufacturing (CMC) · Supplement 5 · standardAP
2014-06-02Manufacturing (CMC) · Supplement 4 · standardAP
2010-10-20Type 7 - Drug Already Marketed without Approved NDA · Original · standard — Summary Review ↗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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