APPLICATION
ANDA210644
TYPE
ANDA
ORIGINAL APPROVAL
2018-02-09
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 19 · standardAP
2024-10-31REMS · Supplement 15AP
2024-03-27Labeling · Supplement 14 · standardAP
2023-12-15Labeling · Supplement 9 · standardAP
2021-03-05Labeling · Supplement 4 · standardAP
2019-10-07Labeling · Supplement 3 · standardAP
2018-09-20Labeling · Supplement 2 · standardAP
2018-09-18REMS · 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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