Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.