APPLICATION
ANDA207419
TYPE
ANDA
ORIGINAL APPROVAL
2017-03-22
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
OXYCODONE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 10MG · TABLET · ORAL
OXYCODONE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 5MG · TABLET · ORAL
OXYCODONE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 7.5MG · TABLET · ORAL
OXYCODONE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 2.5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 21AP
2025-12-22Labeling · Supplement 20 · standardAP
2024-10-31REMS · Supplement 14AP
2024-08-22Labeling · Supplement 15 · standardAP
2024-08-22Labeling · Supplement 13 · standardAP
2023-12-15Labeling · Supplement 12 · standardAP
2023-12-15Labeling · Supplement 11 · standardAP
2021-03-04Labeling · Supplement 10 · standardAP
2019-10-07Labeling · Supplement 6 · standardAP
2018-10-29Manufacturing (CMC) · Supplement 3 · unknownAP
2018-09-20Labeling · Supplement 4 · standardAP
2018-09-18REMS · 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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