APPLICATION
ANDA040330
TYPE
ANDA
ORIGINAL APPROVAL
1999-06-25
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PERCOCETPrescription
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 10MG · TABLET · ORAL
PERCOCETPrescription
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 5MG · TABLET · ORAL
PERCOCETPrescription
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 7.5MG · TABLET · ORAL
PERCOCETPrescription
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 2.5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 65AP
2025-12-22Labeling · Supplement 63 · standardAP
2024-10-31REMS · Supplement 62AP
2024-04-03Labeling · Supplement 61 · standardAP
2023-12-18Labeling · Supplement 58 · standardAP
2023-12-18Labeling · Supplement 59 · standardAP
2021-03-04Labeling · Supplement 57 · standardAP
2019-10-07Labeling · Supplement 55 · standardAP
2018-09-18REMS · Supplement 50 · standardAP
2016-12-16Labeling · Supplement 44 · standardAP
2016-12-16Labeling · Supplement 45 · standardAP
2016-12-16Labeling · Supplement 43 · standardAP
2013-10-18Labeling · Supplement 35 · standardAP
2012-04-10Labeling · Supplement 31AP
2011-06-28Labeling · Supplement 26AP
2004-03-16Labeling · Supplement 14AP
2002-07-31Manufacturing (CMC) · Supplement 7AP
2001-10-18Manufacturing (CMC) · Supplement 6AP
2000-04-12Manufacturing (CMC) · Supplement 4AP
2000-04-12Manufacturing (CMC) · Supplement 5AP
2000-04-12Manufacturing (CMC) · Supplement 3AP
2000-04-12Manufacturing (CMC) · Supplement 1AP
1999-11-02Labeling · 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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