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Embeda Approval History

  • FDA approved: Yes (First approved August 13th, 2009)
  • Brand name: Embeda
  • Generic name: morphine sulfate and naltrexone hydrochloride
  • Dosage form: Extended Release Capsules
  • Company: King Pharmaceuticals , Inc.
  • Treatment for: Pain

Embeda is an abuse-deterrent, extended-release morphine preparation for the treatment of chronic pain.

Development History and FDA Approval Process for Embeda

Oct 17, 2014Approval FDA Approves Labeling with Abuse-Deterrent Features for Embeda (morphine/naltrexone)
Aug 13, 2009Approval FDA Approves Embeda For Management of Moderate to Severe Chronic Pain
Dec 31, 2008King Pharmaceuticals Provides Update on Embeda NDA Review
Sep  2, 2008Alpharma Announces Acceptance of the Embeda Capsule NDA Filing
Jul  1, 2008Alpharma Announces the Resubmission of a New Drug Application for Embeda Capsules
Apr 22, 2008Alpharma to Withdraw and Resubmit Its New Drug Application for Embeda
Feb 29, 2008Alpharma Submits New Drug Application for Embeda

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