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Opana Approval History

  • FDA approved: Yes (First approved June 22nd, 2006)
  • Brand name: Opana
  • Generic name: oxymorphone
  • Dosage form: Tablets and ER Tablets
  • Company: Endo Pharmaceuticals Inc.
  • Treatment for: Pain

Opana ER (extended-release) and Opana (immediate-release) are oral formulations of the opioid analgesic oxymorphone, used for the relief of moderate-to-severe pain. Opana ER is indicated for patients requiring continuous, around-the-clock opioid treatment for an extended period of time, and Opana is indicated for the relief of acute pain where the use of an opioid is appropriate.

Development History and FDA Approval Process for Opana

Dec 12, 2011Approval Endo Announces FDA Approval of a New Formulation of Opana ER Designed to be Crush-Resistant
Jun 22, 2006Approval Opana ER Endo Pharmaceuticals Inc. - Treatment for Moderate-to-Severe Pain
Dec 22, 2005Endo Files Responses to FDA's Approvable Letters on NDAs for Oxymorphone ER and IR Tablets

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