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FDA ANDA · ANDA203506

OXYMORPHONE HYDROCHLORIDE

Sponsor: SUN PHARM INDS LTD

APPLICATION
ANDA203506
TYPE
ANDA
ORIGINAL APPROVAL
2015-04-24
LATEST ACTION
2017-05-26
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

OXYMORPHONE HYDROCHLORIDEDiscontinued
OXYMORPHONE HYDROCHLORIDE 10MG · TABLET, EXTENDED RELEASE · ORAL
OXYMORPHONE HYDROCHLORIDEDiscontinued
OXYMORPHONE HYDROCHLORIDE 5MG · TABLET, EXTENDED RELEASE · ORAL
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

Approval history

2017-05-26REMS · Supplement 7AP
2016-12-16Labeling · Supplement 5 · standardAP
2016-12-16Labeling · Supplement 3 · standardAP
2016-09-30REMS · Supplement 4AP
2016-04-20REMS · Supplement 2AP
2015-06-26REMS · Supplement 1AP
2015-04-24UNKNOWN · Original — Other ↗AP
VIEW ON DRUGS@FDA ↗

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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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