APPLICATION
ANDA040608
TYPE
ANDA
ORIGINAL APPROVAL
2005-12-30
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
OXYCODONE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 300MG, OXYCODONE HYDROCHLORIDE 7.5MG · TABLET · ORAL
OXYCODONE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 300MG, OXYCODONE HYDROCHLORIDE 2.5MG · TABLET · ORAL
OXYCODONE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 300MG, OXYCODONE HYDROCHLORIDE 10MG · TABLET · ORAL
OXYCODONE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 300MG, OXYCODONE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 24AP
2025-12-22Labeling · Supplement 23 · standardAP
2024-10-31REMS · Supplement 22AP
2024-03-12Labeling · Supplement 21 · standardAP
2023-12-15Labeling · Supplement 20 · standardAP
2021-03-04Labeling · Supplement 17 · standardAP
2019-10-08Labeling · Supplement 16 · standardAP
2018-09-21Labeling · Supplement 14 · standardAP
2018-09-18REMS · Supplement 13AP
2018-08-24Labeling · Supplement 12 · standardAP
2016-12-16Labeling · Supplement 11 · standardAP
2016-12-16Labeling · Supplement 10 · standardAP
2013-10-18Labeling · Supplement 8 · standardAP
2011-07-01Labeling · Supplement 7AP
2007-09-25Labeling · 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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