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FDA ANDA · ANDA087463

OXYCODONE AND ACETAMINOPHEN

oxycodone hydrochloride and acetaminophen

Sponsor: SPECGX LLC

APPLICATION
ANDA087463
TYPE
ANDA
ORIGINAL APPROVAL
1983-12-07
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

OXYCETPrescription
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 5MG · TABLET · ORAL

Approval history

2026-06-18REMS · Supplement 60AP
2025-12-29Labeling · Supplement 59 · standardAP
2024-10-31REMS · Supplement 57AP
2024-03-04Labeling · Supplement 56 · standardAP
2023-12-15Labeling · Supplement 54 · standardAP
2023-12-15Labeling · Supplement 55 · standardAP
2021-03-04Labeling · Supplement 49 · standardAP
2019-10-11Labeling · Supplement 45 · standardAP
2018-09-20Labeling · Supplement 43 · standardAP
2018-09-18REMS · Supplement 42AP
2016-12-16Labeling · Supplement 38 · standardAP
2016-12-16Labeling · Supplement 39 · standardAP
2013-10-18Labeling · Supplement 36 · standardAP
2011-06-28Labeling · Supplement 34AP
2007-07-23Labeling · Supplement 30AP
2004-10-25Labeling · Supplement 29AP
2003-01-09Labeling · Supplement 24AP
1999-03-11Manufacturing (CMC) · Supplement 19AP
1999-03-11Labeling · Supplement 20AP
1997-12-17Manufacturing (CMC) · Supplement 17AP
1997-12-17Manufacturing (CMC) · Supplement 15AP
1997-12-17Manufacturing (CMC) · Supplement 13AP
1997-12-17Labeling · Supplement 18AP
1997-12-17Manufacturing (CMC) · Supplement 16AP
1997-12-17Manufacturing (CMC) · Supplement 14AP
1992-06-19Labeling · Supplement 12AP
1991-12-16Labeling · Supplement 11AP
1988-02-18Manufacturing (CMC) · Supplement 8AP
1986-05-20Manufacturing (CMC) · Supplement 9AP
1986-02-13Manufacturing (CMC) · Supplement 7AP
1984-08-10Manufacturing (CMC) · Supplement 2AP
1984-08-10Manufacturing (CMC) · Supplement 3AP
1984-03-29Manufacturing (CMC) · Supplement 1AP
1983-12-07OriginalAP
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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