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, please locate this drug using this index.