FDA ANDA · ANDA202116
OXYCODONE HYDROCHLORIDE
Sponsor: ALVOGEN
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APPLICATION
ANDA202116
TYPE
ANDA
ORIGINAL APPROVAL
2011-12-30
LATEST ACTION
2026-10-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
OXYCODONE HYDROCHLORIDEPrescription
OXYCODONE HYDROCHLORIDE 15MG · TABLET · ORAL
OXYCODONE HYDROCHLORIDEPrescription
OXYCODONE HYDROCHLORIDE 30MG · TABLET · ORAL
OXYCODONE HYDROCHLORIDEPrescription
OXYCODONE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2026-10-08Labeling · Supplement 14 · standardAP
2026-06-18REMS · Supplement 15AP
2025-01-23Labeling · Supplement 13 · standardAP
2025-01-23Labeling · Supplement 8 · standardAP
2025-01-23Labeling · Supplement 6 · standardAP
2025-01-23Labeling · Supplement 4 · standardAP
2025-01-23Labeling · Supplement 12 · standardAP
2025-01-23Labeling · Supplement 10 · standardAP
2024-10-31REMS · Supplement 11AP
2018-09-18REMS · Supplement 5AP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →