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MoxDuo Approval Status beta

  • FDA approved: No
  • Brand name: MoxDuo
  • Generic name: morphine and oxycodone
  • Company: QRxPharma Limited
  • Treatment for: Pain

MoxDuo (morphine and oxycodone) is a narcotic analgesic combination in development for the treatment of moderate to severe acute pain.

FDA Approval Status for MoxDuo

DateArticle
Mar 14, 2013FDA Sets 26 August 2013 As New PDUFA Date For MoxDuo NDA
Feb 28, 2013QRxPharma Resubmits MoxDuo New Drug Application to the FDA
Jan 16, 2013QRxPharma and FDA Establish Path Forward for Resubmission Of Moxduo New Drug Application
Jun 27, 2012QRxPharma Receives Complete Response Letter From FDA Regarding MoxDuo NDA
Nov 11, 2011QRxPharma Granted Target Date for FDA Action on MoxDuo IR NDA: NDA Accepted for Review; PDUFA Date Set for June 25, 2012
Aug 26, 2011QRxPharma Completes NDA Submission for MoxDuo IR
Jul 19, 2011QRxPharma Announces NDA Filing for MoxDuo IR

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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