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… Daunorubicin Hydrochloride for Injection, 5 mg/ml, 4ml vials, Bedford NDA 50-731 1/30/98 1/7/99 Daunorubicin Hydrochloride for Injection, 20 mg (base)/single dose vial, Bigmar ANDA 65-000 5/25/99 5/26/99 Daunorubicin Hydrochloride for Injection, 20 mg (base)/single dose vial, Gensia Sicor ANDA 64-212 6/23/98 6/26/98 Daunorubicin Hydrochloride Injection, 5 mg (base)/mL, (packaged in 20 mg (base)/4 mL and 50 mg (base)/10 mL single-dose vials), Gensia Sicor ANDA 65-035 1/24/00 2/4/00 Daunorubicin Hydrochloride Injection, 5 mg (base)/mL, (packaged in 20 mg (base)/4 mL single-dose vials), SuperGen, ANDA 65-034 11/20/01 10/10/02 DaunoXome (daunorubicin citrate liposome injection), Gilead Sciences, NDA 50-704/S-008 DAUNORUBICIN CITRATE Injectable, Liposomal; Injection 2MG BASE/ML DAUNOXOME GILEAD 064103 DAUNORUBICIN HYDROCHLORIDE Injection 20MG BASE/VIAL CERUBIDINE Bedford 050731 DAUNORUBICIN HYDROCHLORIDE Injection 5MG BASE/ML DAUNORUBICIN HCL Bedford 065000 DAUNORUBICIN HYDROCHLORIDE Injection 20MG BASE/VIAL DAUNORUBICIN HCL BIGMAR 064212 DAUNORUBICIN HYDROCHLORIDE Injection 20MG BASE/VIAL DAUNORUBICIN HCL Gensia Sicor 064212 DAUNORUBICIN HYDROCHLORIDE Injection 50MG BASE/VIAL DAUNORUBICIN HCL Gensia Sicor 065035 DAUNORUBICIN HYDROCHLORIDE Injection 5MG BASE/ML DAUNORUBICIN HCL Gensia Sicor 065034 DAUNORUBICIN HYDROCHLORIDE Injection 5MG BASE/VIAL DAUNORUBICIN HCL SUPERGEN   For the latest approval information, locate this drug using this index.