APPLICATION
ANDA090734
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 7.5MG · TABLET · ORAL
OXYCODONE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 33AP
2025-12-23Labeling · Supplement 32 · standardAP
2024-10-31REMS · Supplement 31AP
2024-04-03Labeling · Supplement 30 · standardAP
2023-12-18Labeling · Supplement 29 · standardAP
2023-12-18Labeling · Supplement 28 · standardAP
2021-03-04Labeling · Supplement 27 · standardAP
2019-10-08Labeling · Supplement 24 · standardAP
2018-09-21Labeling · Supplement 22 · standardAP
2018-09-18REMS · Supplement 19 · standardAP
2016-12-16Labeling · Supplement 16 · standardAP
2016-12-16Labeling · Supplement 14 · standardAP
2016-12-16Labeling · Supplement 12 · 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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