APPLICATION
ANDA091393
TYPE
ANDA
ORIGINAL APPROVAL
2009-08-31
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
OXYCODONE HYDROCHLORIDEPrescription
OXYCODONE HYDROCHLORIDE 30MG · TABLET · ORAL
OXYCODONE HYDROCHLORIDEPrescription
OXYCODONE HYDROCHLORIDE 15MG · TABLET · ORAL
OXYCODONE HYDROCHLORIDEPrescription
OXYCODONE HYDROCHLORIDE 5MG · TABLET · ORAL
OXYCODONE HYDROCHLORIDEPrescription
OXYCODONE HYDROCHLORIDE 20MG · TABLET · ORAL
OXYCODONE HYDROCHLORIDEPrescription
OXYCODONE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 34AP
2024-10-31REMS · Supplement 28AP
2018-09-18REMS · Supplement 15AP
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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