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FDA Approval Activities for this Drug…
Buprenex (buprenorphine hydrochloride) Injectable, Reckitt Benckiser NDA 18-401/S-015 6/10/03 7/8/03 Buprenex (buprenorphine hydrochloride) Injectable, Reckitt Benckiser NDA 18-401/S-014 Subutex (buprenorphine HCl) and Suboxone (buprenorphine HCl and naloxone HCl dihydrate) tablets, Reckitt Benckiser NDA 20-732 & 20-733 | Buprenorphine Hydrochloride Injection, Bedford Laboratories, Approval | Subutex (buprenorphine HCl), Reckitt Benckiser, Labeling Revision | Suboxone (buprenorphine HCl and naloxone HCl), Reckitt Benckiser, Labeling Revision | Buprenorphine Hydrochloride Injection, PharmaForce Inc., Approval | Buprenorphine Hydrochloride Tablets, Roxane Laboratories, Inc., Tentative Approval | Buprenorphine Hydrochloride Tablets, Roxane Laboratories, Inc., Approval | Buprenorphine Hydrochloride Tablets, Barr Laboratories, Inc., Approval | Butrans (buprenorphine) Transdermal System, Purdue Pharma L.P., Approval | Suboxone (buprenorphine and naloxone) Film Oral, Reckitt Benckiser Pharmaceuticals Inc., Approval | Suboxone (buprenorphine and naloxone) Oral Soluble Film, Reckitt Benckiser Pharmaceuticals Inc., Labeling Revision | Buprenorphine Hydrochloride Sublingual Tablets, Ethypharm USA Corporation, Approval | Butrans (buprenorphine) Film, Purdue Pharma L.P., Labeling Revision | Suboxone, buprenorphine hydrochloride; naloxone hydrochloride, Tablet; Sublingual, Reckitt Benckiser, Labeling Revision | Subutex, buprenorphine hydrochloride, Tablet; Sublingual, Reckitt Benckiser, Labeling Revision
  
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