APPLICATION
ANDA203864
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-02
LATEST ACTION
2025-12-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
OXYCODONE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 10MG · TABLET · ORAL
OXYCODONE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 5MG · TABLET · ORAL
OXYCODONE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 7.5MG · TABLET · ORAL
Approval history
2025-12-23Labeling · Supplement 11 · standardAP
2024-09-19Labeling · Supplement 10 · standardAP
2024-02-28Labeling · Supplement 9 · standardAP
2024-02-26Labeling · Supplement 8 · standardAP
2021-03-04Labeling · Supplement 6 · standardAP
2019-10-08Labeling · Supplement 4 · standardAP
2019-09-27Labeling · Supplement 3 · standardAP
2018-07-02UNKNOWN · OriginalAP
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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