Business · 25/06/2013Updated: 10/17/2026 · 1 min read

FDA Clears Oxymorphone Hydrochloride Extended-Release Tablets for Approval

Summary

The US Food and Drug Administration (FDA) has ruled that Oxymorphone Hydrochloride (OPANA ER) Extended-Release Tablet products, approved under NDA 21-610, were not withdrawn from sale due to safety or effectiveness concerns, allowing the FDA to approve future abbreviated new drug applications (ANDAs) for these products.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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