APPLICATION
ANDA204037
TYPE
ANDA
ORIGINAL APPROVAL
2013-07-15
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
OXYCODONE HYDROCHLORIDEPrescription
OXYCODONE HYDROCHLORIDE 5MG/5ML · SOLUTION · ORAL
Approval history
2026-06-18REMS · Supplement 18AP
2025-12-22Labeling · Supplement 16 · standardAP
2025-12-09Labeling · Supplement 8 · standardAP
2025-12-09Labeling · Supplement 6 · standardAP
2025-12-09Labeling · Supplement 10 · standardAP
2025-12-09Labeling · Supplement 15 · standardAP
2025-12-09Labeling · Supplement 13 · standardAP
2025-12-09Labeling · Supplement 11 · standardAP
2024-10-31REMS · Supplement 14AP
2018-09-18REMS · Supplement 7AP
2014-09-04Manufacturing (CMC) · Supplement 2 · unknownAP
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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