← FDA DRUG APPROVALS

FDA NDA · NDA021011

ROXICODONE

oxycodone hydrochloride

Sponsor: SPECGX LLC

APPLICATION
NDA021011
TYPE
NDA
ORIGINAL APPROVAL
2000-08-31
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ROXICODONE · ReferencePrescription
OXYCODONE HYDROCHLORIDE 30MG · TABLET · ORAL
ROXICODONE · ReferencePrescription
OXYCODONE HYDROCHLORIDE 5MG · TABLET · ORAL
ROXICODONE · ReferencePrescription
OXYCODONE HYDROCHLORIDE 15MG · 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 11 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 10 · standard — Label ↗AP
2018-09-18REMS · Supplement 8 — Letter ↗AP
2018-09-18Labeling · Supplement 9 · standard — Letter ↗AP
2016-12-16Labeling · Supplement 6 · standard — Letter ↗AP
2009-05-15Manufacturing (CMC) · Supplement 3 — Label ↗AP
2009-02-20Labeling · Supplement 2 · standard — Letter ↗AP
2000-08-31Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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