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… Nalbuphine Hydrochloride Injection, 10 mg/mL & 20 mg/mL. King ANDA 74-471 Nubain (nalbuphine hydrochloride) Injection, Endo NDA 18-024/036 NALBUPHINE HYDROCHLORIDE Injection 10MG/ML NALBUPHINE HCL Abbott 070915 NALBUPHINE HYDROCHLORIDE Injection 10MG/ML NALBUPHINE HCL Abbott 070916 NALBUPHINE HYDROCHLORIDE Injection 20MG/ML NALBUPHINE HCL Abbott 070917 NALBUPHINE HYDROCHLORIDE Injection 20MG/ML NALBUPHINE HCL Abbott 070918 NALBUPHINE HYDROCHLORIDE Injection 20MG/ML NALBUPHINE HCL Abbott 018024 NALBUPHINE HYDROCHLORIDE Injection 10MG/ML NUBAIN ENDO 018024 NALBUPHINE HYDROCHLORIDE Injection 20MG/ML NUBAIN ENDO   For the latest approval information, locate this drug using this index.