APPLICATION
ANDA202946
TYPE
ANDA
ORIGINAL APPROVAL
2014-06-27
LATEST ACTION
2021-03-04
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
OXYMORPHONE HYDROCHLORIDEDiscontinued
OXYMORPHONE HYDROCHLORIDE 30MG · TABLET, EXTENDED RELEASE · ORAL
OXYMORPHONE HYDROCHLORIDEDiscontinued
OXYMORPHONE HYDROCHLORIDE 15MG · TABLET, EXTENDED RELEASE · ORAL
OXYMORPHONE HYDROCHLORIDEDiscontinued
OXYMORPHONE HYDROCHLORIDE 7.5MG · TABLET, EXTENDED RELEASE · ORAL
OXYMORPHONE HYDROCHLORIDEDiscontinued
OXYMORPHONE HYDROCHLORIDE 40MG · TABLET, EXTENDED RELEASE · ORAL
OXYMORPHONE HYDROCHLORIDEDiscontinued
OXYMORPHONE HYDROCHLORIDE 20MG · TABLET, EXTENDED RELEASE · ORAL
OXYMORPHONE HYDROCHLORIDEDiscontinued
OXYMORPHONE HYDROCHLORIDE 10MG · TABLET, EXTENDED RELEASE · ORAL
OXYMORPHONE HYDROCHLORIDEDiscontinued
OXYMORPHONE HYDROCHLORIDE 5MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2021-03-04Labeling · Supplement 11 · standardAP
2019-10-11Labeling · Supplement 10 · standardAP
2018-09-20Labeling · Supplement 9 · standardAP
2018-09-18REMS · Supplement 8AP
2017-05-26REMS · Supplement 7AP
2016-12-16Labeling · Supplement 6 · standardAP
2016-12-16Labeling · Supplement 4 · standardAP
2016-09-30REMS · Supplement 5AP
2016-04-20REMS · Supplement 3AP
2015-06-26REMS · Supplement 2AP
2014-08-19REMS · 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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