APPLICATION
ANDA090535
TYPE
ANDA
ORIGINAL APPROVAL
2013-12-26
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 2.5MG · TABLET · ORAL
OXYCODONE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 10MG · TABLET · ORAL
OXYCODONE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 21AP
2025-12-23Labeling · Supplement 20 · standardAP
2024-10-31REMS · Supplement 19AP
2024-02-29Labeling · Supplement 17 · standardAP
2024-02-29Labeling · Supplement 18 · standardAP
2023-12-15Labeling · Supplement 16 · standardAP
2021-03-04Labeling · Supplement 15 · standardAP
2019-10-09Labeling · Supplement 14 · standardAP
2018-09-20Labeling · Supplement 11 · standardAP
2018-09-18REMS · Supplement 10AP
2016-12-16Labeling · Supplement 6 · standardAP
2016-12-16Labeling · Supplement 4 · standardAP
2016-12-16Labeling · Supplement 5 · 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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