APPLICATION
ANDA076636
TYPE
ANDA
ORIGINAL APPROVAL
2004-02-06
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
OXYCODONE HYDROCHLORIDEDiscontinued
OXYCODONE HYDROCHLORIDE 5MG · TABLET · ORAL
OXYCODONE HYDROCHLORIDEDiscontinued
OXYCODONE HYDROCHLORIDE 15MG · TABLET · ORAL
OXYCODONE HYDROCHLORIDEDiscontinued
OXYCODONE HYDROCHLORIDE 30MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 42AP
2024-10-31REMS · Supplement 40AP
2018-09-18REMS · Supplement 35AP
2015-04-07Labeling · Supplement 5AP
2009-06-12Labeling · Supplement 17AP
2004-06-18Labeling · Supplement 1AP
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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