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Butrans Approval History

  • FDA approved: Yes (First approved June 30th, 2010)
  • Brand name: Butrans
  • Generic name: buprenorphine
  • Dosage form: Transdermal System
  • Company: Purdue Pharma L.P.
  • Treatment for: Pain

Butrans (buprenorphine) is a transdermal opioid analgesic for the management of moderate to severe chronic pain in patients requiring continuous treatment for an extended period of time.

Development History and FDA Approval Process for Butrans

Sep 24, 2013Approval Purdue Pharma L.P. Receives FDA Approval For 15 mcg/hour Dosage Strength Of Butrans (buprenorphine) Transdermal System CIII
Jul  1, 2010Approval Purdue Pharma L.P. Receives FDA Approval for Butrans (buprenorphine) Transdermal System CIII

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