APPLICATION
ANDA089351
TYPE
ANDA
ORIGINAL APPROVAL
1986-12-03
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
ROXICETDiscontinued
ACETAMINOPHEN 325MG/5ML, OXYCODONE HYDROCHLORIDE 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL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 41AP
2025-12-22Labeling · Supplement 39 · standardAP
2024-10-31REMS · Supplement 37AP
2024-03-14Labeling · Supplement 36 · standardAP
2023-12-15Labeling · Supplement 35 · standardAP
2023-12-15Labeling · Supplement 34 · standardAP
2021-03-04Labeling · Supplement 33 · standardAP
2019-10-08Labeling · Supplement 31 · standardAP
2018-09-21Labeling · Supplement 30 · standardAP
2018-09-18REMS · Supplement 29AP
2016-12-16Labeling · Supplement 28 · standardAP
2013-10-18Labeling · Supplement 26 · standardAP
2011-06-28Labeling · Supplement 25AP
2007-08-29Labeling · Supplement 23AP
2002-05-15Manufacturing (CMC) · Supplement 18AP
2001-06-01Labeling · Supplement 17AP
2000-12-18Manufacturing (CMC) · Supplement 16AP
2000-12-18Manufacturing (CMC) · Supplement 15AP
1999-02-16Manufacturing (CMC) · Supplement 13AP
1998-11-16Manufacturing (CMC) · Supplement 14AP
1997-11-12Manufacturing (CMC) · Supplement 10AP
1997-11-12Manufacturing (CMC) · Supplement 11AP
1996-08-28Manufacturing (CMC) · Supplement 9AP
1995-09-22Manufacturing (CMC) · Supplement 8AP
1994-02-16Labeling · Supplement 7AP
1991-05-29Labeling · Supplement 6AP
1989-02-15Labeling · Supplement 5AP
1989-02-15Labeling · Supplement 2AP
1989-02-15Labeling · Supplement 40AP
1988-07-01Manufacturing (CMC) · Supplement 3AP
1988-07-01Manufacturing (CMC) · Supplement 4AP
1986-12-03OriginalAP
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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