APPLICATION
ANDA090733
TYPE
ANDA
ORIGINAL APPROVAL
2013-07-11
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
OXYCODONE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 2.5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 27AP
2025-12-22Labeling · Supplement 26 · standardAP
2024-10-31REMS · Supplement 25AP
2024-04-09Labeling · Supplement 24 · standardAP
2023-12-18Labeling · Supplement 23 · standardAP
2023-12-18Labeling · Supplement 22 · standardAP
2021-03-04Labeling · Supplement 21 · standardAP
2019-10-07Labeling · Supplement 18 · standardAP
2018-09-21Labeling · Supplement 16 · standardAP
2018-09-18REMS · Supplement 14 · standardAP
2016-12-16Labeling · Supplement 11 · standardAP
2016-12-16Labeling · Supplement 7 · standardAP
2016-12-16Labeling · Supplement 10 · standardAP
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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