APPLICATION
ANDA207574
TYPE
ANDA
ORIGINAL APPROVAL
2016-12-13
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
OXYCODONE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 14AP
2026-01-06Labeling · Supplement 13 · standardAP
2024-11-20REMS · Supplement 11AP
2024-09-19Labeling · Supplement 12 · standardAP
2023-12-15Labeling · Supplement 9 · standardAP
2023-12-15Labeling · Supplement 10 · standardAP
2021-03-04Labeling · Supplement 8 · standardAP
2019-10-08Labeling · Supplement 7 · standardAP
2018-09-21Labeling · Supplement 5 · standardAP
2018-09-20Labeling · Supplement 1 · standardAP
2018-09-18REMS · 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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