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FDA ANDA · ANDA209385
OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN
Sponsor: ELITE LABS INC
APPLICATION
ANDA209385
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-02
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
OXYCODONE AND ACETAMINOPHENPrescription
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 17AP
2025-12-23Labeling · Supplement 15 · standardAP
2024-10-31REMS · Supplement 11AP
2024-10-15Labeling · Supplement 10 · standardAP
2024-10-15Labeling · Supplement 13 · standardAP
2023-12-15Labeling · Supplement 8 · standardAP
2023-12-15Labeling · Supplement 9 · standardAP
2021-03-05Labeling · Supplement 7 · standardAP
2019-10-08Labeling · Supplement 6 · standardAP
2019-10-04Labeling · Supplement 4 · standardAP
2018-09-18REMS · 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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