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Zohydro ER Approval History

  • FDA approved: Yes (First approved October 25th, 2013)
  • Brand name: Zohydro ER
  • Generic name: hydrocodone
  • Dosage form: Extended-Release Capsules
  • Company: Zogenix, Inc.
  • Treatment for: Pain

Zohydro ER (hydrocodone) is a single-entity (without acetaminophen) extended-release opioid analgesic for around-the-clock management of moderate to severe chronic pain.

Development History and FDA Approval Process for Zohydro ER

Jan 30, 2015Approval Zogenix Receives FDA Approval for New Abuse-Deterrent Formulation of Zohydro ER
Oct 25, 2013Approval FDA Approves Zohydro ER, an Extended-Release, Single-Entity Hydrocodone Product
Feb 27, 2013Zogenix Provides Update on Zohydro ER Regulatory Review
Dec 10, 2012Zogenix Provides Update on FDA Advisory Committee Meeting for Zohydro ER for Management of Chronic Pain
Nov 16, 2012Zogenix Announces FDA Advisory Committee Review of Zohydro ER for the Management of Chronic Pain
Jul 16, 2012Zogenix Announces U.S. Food and Drug Administration (FDA) Acceptance for Review of Zohydro ER New Drug Application (NDA) for Treatment of Chronic Pain
May  2, 2012Zogenix Submits New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Zohydro for Treatment of Chronic Pain

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