APPLICATION
ANDA087003
TYPE
ANDA
ORIGINAL APPROVAL
1980-02-25
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ROXICET · ReferenceDiscontinued
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 52AP
2025-12-22Labeling · Supplement 50 · standardAP
2024-10-31REMS · Supplement 48AP
2024-03-07Labeling · Supplement 47 · standardAP
2023-12-15Labeling · Supplement 46 · standardAP
2021-03-04Labeling · Supplement 45 · standardAP
2019-10-08Labeling · Supplement 43 · standardAP
2018-09-21Labeling · Supplement 42 · standardAP
2018-09-18REMS · Supplement 41AP
2016-12-16Labeling · Supplement 38 · standardAP
2016-12-16Labeling · Supplement 39 · standardAP
2014-08-12Labeling · Supplement 36 · standardAP
2013-10-18Labeling · Supplement 35 · standardAP
2011-06-28Labeling · Supplement 34AP
2007-08-29Labeling · Supplement 27AP
2001-06-05Labeling · Supplement 20AP
1999-03-22Manufacturing (CMC) · Supplement 19AP
1996-08-28Manufacturing (CMC) · Supplement 18AP
1995-06-19Manufacturing (CMC) · Supplement 17AP
1994-09-15Manufacturing (CMC) · Supplement 14AP
1993-09-23Labeling · Supplement 16AP
1993-05-13Labeling · Supplement 15AP
1991-05-29Labeling · Supplement 13AP
1991-02-01Labeling · Supplement 7AP
1991-02-01Manufacturing (CMC) · Supplement 8AP
1991-02-01Manufacturing (CMC) · Supplement 6AP
1989-08-29Labeling · Supplement 9AP
1988-10-21Manufacturing (CMC) · Supplement 11AP
1988-10-21Manufacturing (CMC) · Supplement 12AP
1988-10-21Manufacturing (CMC) · Supplement 10AP
1982-09-01Manufacturing (CMC) · Supplement 1AP
1982-03-29Manufacturing (CMC) · Supplement 2AP
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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