APPLICATION
ANDA202677
TYPE
ANDA
ORIGINAL APPROVAL
2012-07-26
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
Approval history
2026-06-18REMS · Supplement 22AP
2025-12-23Labeling · Supplement 21 · standardAP
2024-10-31REMS · Supplement 19AP
2024-03-13Labeling · Supplement 18 · standardAP
2023-12-15Labeling · Supplement 17 · standardAP
2021-03-05Labeling · Supplement 16 · standardAP
2019-10-07Labeling · Supplement 14 · standardAP
2018-09-20Labeling · Supplement 11 · standardAP
2018-09-18REMS · Supplement 10AP
2016-12-16Labeling · Supplement 7 · standardAP
2016-12-16Labeling · Supplement 6 · standardAP
2016-03-08Manufacturing (CMC) · Supplement 5AP
2013-10-18Labeling · Supplement 1 · 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.
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