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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 ^ FDA's latest approval appears at the bottom of this list. ^                                                                                      A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2009 Betterchem.com