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Zubsolv Approval History

  • FDA approved: Yes (First approved July 3rd, 2013)
  • Brand name: Zubsolv
  • Generic name: buprenorphine and naloxone
  • Dosage form: Sublingual Tablets
  • Company: Orexo AB
  • Treatment for: Opiate Dependence

Zubsolv (buprenorphine and naloxone) is a sublingual partial opioid agonist indicated for the maintenance treatment of opioid dependence.

Development History and FDA Approval Process for Zubsolv

Oct  6, 2016Approval FDA Approves Unique Low Dosage of Zubsolv
Aug 11, 2015Approval FDA Approves Zubsolv for Induction of Buprenorphine Maintenance Therapy in Patients Suffering from Opioid Dependence
Dec 12, 2014Approval FDA Approves Two Higher Dosage Strengths of Zubsolv
Jul  8, 2013Approval FDA Approves Zubsolv for the Maintenance Treatment of Opioid Dependence
Nov 19, 2012Orexo announces that Zubsolv has been accepted for review by the U.S. Food and Drug Administration (FDA)

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