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FDA NDA · NDA202080

OXAYDO

oxycodone hydrochloride

Sponsor: ZYLA

APPLICATION
NDA202080
TYPE
NDA
ORIGINAL APPROVAL
2011-06-17
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

OXAYDO · ReferenceDiscontinued
OXYCODONE HYDROCHLORIDE 7.5MG · TABLET · ORAL
OXAYDO · ReferenceDiscontinued
OXYCODONE HYDROCHLORIDE 5MG · TABLET · ORAL

Approval history

2026-06-18REMS · Supplement 17 — Letter ↗AP
2025-12-22Labeling · Supplement 16 · 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
2021-03-04Labeling · Supplement 12 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 11 · standard — Letter ↗AP
2018-09-18Labeling · Supplement 10 · standard — Label ↗AP
2018-09-18REMS · Supplement 9 — Label ↗AP
2016-12-16Labeling · Supplement 5 · standard — Label ↗AP
2016-12-16Labeling · Supplement 6 · standard — Label ↗AP
2016-03-07Manufacturing (CMC) · Supplement 4 · priorityAP
2015-01-26Labeling · Supplement 3 · standard — Label ↗AP
2014-01-16Labeling · Supplement 2 · standard — Label ↗AP
2013-06-03Labeling · Supplement 1 · standard — Label ↗AP
2011-06-17Type 5 - New Formulation or New Manufacturer · Original · priority — 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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