General MedicationsORALGeneric

OPANA ER

OXYMORPHONE HYDROCHLORIDE

Standard Dose

40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Max Dose

Refer to approved labeling

Primary Use

Review priority: N/A Marketing status: Discontinued

Summary

Approval overview OPANA ER is listed in Drugs@FDA under application 021610 (NDA).

Review priority: N/A Marketing status: Discontinued Active ingredient OXYMORPHONE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ENDO OPERATIONS Submission history Latest submission status date: 2024-10-31 00:00:00.

Structured Monograph

Clinical summary

Approval overview OPANA ER is listed in Drugs@FDA under application 021610 (NDA). Review priority: N/A Marketing status: Discontinued Active ingredient OXYMORPHONE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ENDO OPERATIONS Submission history Latest submission status date: 2024-10-31 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: N/A

Interaction Notes

No interaction notes stored yet.