APPLICATION
ANDA204603
TYPE
ANDA
ORIGINAL APPROVAL
2015-04-29
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
OXYCODONE HYDROCHLORIDEDiscontinued
OXYCODONE HYDROCHLORIDE 100MG/5ML · SOLUTION · ORAL
Approval history
2026-06-18REMS · Supplement 15AP
2026-01-06Labeling · Supplement 13 · standardAP
2026-01-06Labeling · Supplement 11 · standardAP
2026-01-06Labeling · Supplement 14 · standardAP
2026-01-06Labeling · Supplement 10 · standardAP
2024-10-31REMS · Supplement 12AP
2020-04-06Labeling · Supplement 6 · standardAP
2020-04-06Labeling · Supplement 2 · standardAP
2020-04-06Labeling · Supplement 7 · standardAP
2018-09-18REMS · Supplement 3AP
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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