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FDA ANDA · ANDA040545
OXYCODONE AND ACETAMINOPHEN
oxycodone hydrochloride and acetaminophen
Sponsor: SPECGX LLC
APPLICATION
ANDA040545
TYPE
ANDA
ORIGINAL APPROVAL
2004-06-30
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
OXYCODONE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 7.5MG · TABLET · ORAL
OXYCODONE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 31AP
2025-12-29Labeling · Supplement 30 · standardAP
2024-10-31REMS · Supplement 28AP
2024-03-04Labeling · Supplement 27 · standardAP
2023-12-15Labeling · Supplement 26 · standardAP
2021-03-04Labeling · Supplement 21 · standardAP
2019-10-11Labeling · Supplement 17 · standardAP
2018-09-20Labeling · Supplement 16 · standardAP
2018-09-18REMS · Supplement 15AP
2016-12-16Labeling · Supplement 11 · standardAP
2016-12-16Labeling · Supplement 12 · standardAP
2013-10-18Labeling · Supplement 9 · standardAP
2011-06-28Labeling · Supplement 7AP
2008-01-26Manufacturing (CMC) · Supplement 4AP
2007-07-23Labeling · Supplement 3AP
2004-10-25Labeling · Supplement 2AP
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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