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

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