APPLICATION
ANDA204979
TYPE
ANDA
ORIGINAL APPROVAL
2015-06-01
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 22AP
2025-12-23Labeling · Supplement 20 · standardAP
2025-12-09Labeling · Supplement 18 · standardAP
2025-12-09Labeling · Supplement 16 · standardAP
2025-12-09Labeling · Supplement 10 · standardAP
2025-12-09Labeling · Supplement 9 · standardAP
2024-10-31REMS · Supplement 17AP
2020-09-11Manufacturing (CMC) · Supplement 8 · unknownAP
2020-09-11Labeling · Supplement 2 · standardAP
2020-09-11Labeling · Supplement 7 · standardAP
2018-09-18REMS · Supplement 4AP
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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