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Zubsolv FDA Approval History

FDA Approved: Yes (First approved July 3, 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 Timeline 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)

Further information

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