APPLICATION
ANDA201278
TYPE
ANDA
ORIGINAL APPROVAL
2014-08-28
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
OXYCODONE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 7.5MG · TABLET · ORAL
OXYCODONE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 10MG · TABLET · ORAL
OXYCODONE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 23AP
2025-12-23Labeling · Supplement 22 · standardAP
2024-04-03Labeling · Supplement 20 · standardAP
2023-12-15Labeling · Supplement 19 · standardAP
2021-03-04Labeling · Supplement 15 · standardAP
2019-10-08Labeling · Supplement 10 · standardAP
2018-10-23Labeling · Supplement 9 · standardAP
2018-10-12Manufacturing (CMC) · Supplement 7 · unknownAP
2018-09-18REMS · Supplement 6AP
2017-02-10Labeling · Supplement 5 · standardAP
2017-02-10Labeling · Supplement 3 · standardAP
2017-02-10Labeling · Supplement 4 · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.