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FDA NDA · NDA201194

OXYCODONE HYDROCHLORIDE

Sponsor: VISTAPHARM LLC

APPLICATION
NDA201194
TYPE
NDA
ORIGINAL APPROVAL
2012-01-12
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

OXYCODONE HYDROCHLORIDE · ReferenceDiscontinued
OXYCODONE HYDROCHLORIDE 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL

Approval history

2026-06-18REMS · Supplement 22 — Letter ↗AP
2025-12-22Labeling · Supplement 21 · standard — Letter ↗AP
2024-10-31REMS · Supplement 20 — Letter ↗AP
2024-04-19Labeling · Supplement 19 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 17 · standard — Label ↗AP
2021-07-21Efficacy · Supplement 9 · standard — Letter ↗AP
2021-03-04Labeling · Supplement 10 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 8 · standard — Label ↗AP
2018-09-18REMS · Supplement 3 — Label ↗AP
2018-09-18Labeling · Supplement 4 · standard — Label ↗AP
2016-12-16Labeling · Supplement 2 · standard — Label ↗AP
2014-06-02Manufacturing (CMC) · Supplement 1 · standardAP
2012-01-12Type 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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