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FDA NDA · NDA200535

OXYCODONE HYDROCHLORIDE

Sponsor: GENUS LIFESCIENCES

APPLICATION
NDA200535
TYPE
NDA
ORIGINAL APPROVAL
2010-10-20
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

OXYCODONE HYDROCHLORIDE · ReferencePrescription
OXYCODONE HYDROCHLORIDE 100MG/5ML · SOLUTION · ORAL
OXYCODONE HYDROCHLORIDE · ReferencePrescription
OXYCODONE HYDROCHLORIDE 5MG/5ML · SOLUTION · ORAL

Approval history

2026-06-18REMS · Supplement 27 — Letter ↗AP
2025-12-22Labeling · Supplement 26 · standard — Letter ↗AP
2024-10-31REMS · Supplement 24 — Letter ↗AP
2024-04-19Labeling · Supplement 23 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 22 · standard — Label ↗AP
2021-07-21Efficacy · Supplement 17 · standard — Letter ↗AP
2021-03-04Labeling · Supplement 19 · standard — Label ↗AP
2019-10-07Labeling · Supplement 16 · standard — Label ↗AP
2018-09-18Labeling · Supplement 15 · standard — Label ↗AP
2018-09-18REMS · Supplement 14 — Label ↗AP
2016-12-16Labeling · Supplement 11 · standard — Label ↗AP
2015-09-01Manufacturing (CMC) · Supplement 10 · standardAP
2014-06-20Manufacturing (CMC) · Supplement 9 · standard — Label ↗AP
2013-10-08Manufacturing (CMC) · Supplement 7 · standardAP
2013-08-22Manufacturing (CMC) · Supplement 8 · standard — Label ↗AP
2013-08-22Labeling · Supplement 6 · standard — Label ↗AP
2012-01-25REMS · Supplement 4 — Letter ↗AP
2010-10-20Type 7 - Drug Already Marketed without Approved NDA · Original · standard — Label ↗AP
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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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