APPLICATION
ANDA090659
TYPE
ANDA
ORIGINAL APPROVAL
2009-04-10
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 20MG · TABLET · ORAL
OXYCODONE HYDROCHLORIDEDiscontinued
OXYCODONE HYDROCHLORIDE 15MG · TABLET · ORAL
OXYCODONE HYDROCHLORIDEDiscontinued
OXYCODONE HYDROCHLORIDE 10MG · TABLET · ORAL
OXYCODONE HYDROCHLORIDEDiscontinued
OXYCODONE HYDROCHLORIDE 30MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 28AP
2024-10-31REMS · Supplement 27AP
2018-09-18REMS · Supplement 18AP
2017-03-24Labeling · Supplement 15 · standardAP
2012-11-06Manufacturing (CMC) · 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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