Opioid Use Disorder

• FDA label_change · 2025-12-22
  FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)

  The FDA approved a supplemental labeling change for ZUBSOLV (buprenorphine/naloxone) from Orexo US, Inc., updating the product labeling.

• FDA label_change · 2023-12-15
  FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)

  FDA approved a supplemental application for ZUBSOLV, resulting in updated labeling for buprenorphine/naloxone.

• FDA label_change · 2016-12-16
  FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)

  The FDA approved a supplemental application for ZUBSOLV (buprenorphine hydrochloride and naloxone hydrochloride) by Orexo US, Inc., resultin…

• FDA label_change · 2015-08-10
  FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)

  FDA approved a supplemental application for ZUBSOLV, resulting in labeling changes for the buprenorphine/naloxone product from Orexo US, Inc…

• FDA label_change · 2015-02-12
  FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for buprenorphine and naloxone from Actavis Pharma, Inc., resulting in a labeling change for the pro…

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• FDA label_change · 2013-07-29
  FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)

  The FDA approved a supplemental application for VIVITROL (naltrexone) from Alkermes, Inc., resulting in changes to the product label.