APPLICATION
ANDA202773
TYPE
ANDA
ORIGINAL APPROVAL
2015-08-17
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
OXYCODONE HYDROCHLORIDEPrescription
OXYCODONE HYDROCHLORIDE 5MG · CAPSULE · ORAL
Approval history
2026-06-18REMS · Supplement 15AP
2025-09-25Labeling · Supplement 1 · standardAP
2025-09-25Labeling · Supplement 11 · standardAP
2024-10-31REMS · Supplement 9AP
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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