APPLICATION
ANDA040171
TYPE
ANDA
ORIGINAL APPROVAL
1997-10-30
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
OXYCODONE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 42AP
2025-12-23Labeling · Supplement 41 · standardAP
2024-10-31REMS · Supplement 40AP
2024-02-29Labeling · Supplement 39 · standardAP
2024-02-29Labeling · Supplement 38 · standardAP
2023-12-15Labeling · Supplement 37 · standardAP
2021-03-04Labeling · Supplement 36 · standardAP
2019-10-08Labeling · Supplement 35 · standardAP
2018-09-21Labeling · Supplement 34 · standardAP
2018-09-18REMS · Supplement 33AP
2016-12-16Labeling · Supplement 31 · standardAP
2016-12-16Labeling · Supplement 32 · standardAP
2013-10-18Labeling · Supplement 30 · standardAP
2011-07-19Labeling · Supplement 27AP
2008-12-19Labeling · Supplement 19AP
2001-04-12Manufacturing (CMC) · Supplement 3AP
2000-03-21Manufacturing (CMC) · Supplement 2AP
1998-08-21Manufacturing (CMC) · Supplement 1AP
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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