APPLICATION
ANDA040777
TYPE
ANDA
ORIGINAL APPROVAL
2007-11-27
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
OXYCODONE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 33AP
2025-12-29Labeling · Supplement 31 · standardAP
2024-10-31REMS · Supplement 30AP
2024-08-22Labeling · Supplement 29 · standardAP
2024-02-23Labeling · Supplement 27 · standardAP
2024-02-23Labeling · Supplement 28 · standardAP
2024-02-21Labeling · Supplement 25 · standardAP
2021-03-04Labeling · Supplement 23 · standardAP
2019-10-07Labeling · Supplement 17 · standardAP
2018-09-21Labeling · Supplement 13 · standardAP
2018-09-18REMS · Supplement 14AP
2016-12-16Labeling · Supplement 11 · standardAP
2016-12-16Labeling · Supplement 12 · standardAP
2013-10-18Labeling · Supplement 8 · standardAP
2011-06-29Labeling · Supplement 6AP
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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